Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-03 @ 8:15 PM
Study NCT ID:
NCT02371759
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2015-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lidocaine + Clonidine for Intraoral Anesthesia in Patients With Diabetes Mellitus Type 2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'brkovic73@yahoo.com', 'phone': '+ 381 11 2685 280', 'title': 'DDS PhD Professor Dragica Stojic, DDS PhD Professor Bozidar Brkovic, DDS PhD Marija Milic', 'phoneExt': '244', 'organization': 'University of Belgrade, Faculty of Dental Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '7 days', 'eventGroups': [{'id': 'EG000', 'title': 'Diabetics: L+C Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia\n\nL+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Diabetics: L+C Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia\n\nL+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Diabetics: L+E Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)', 'otherNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Diabetics: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)', 'otherNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Healthy: L+C Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia\n\nL+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Healthy: L+C Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia\n\nL+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Healthy: L+E Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Healthy: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of Intraoral Local Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '25', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetics: L+C Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia\n\nL+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG001', 'title': 'Diabetics: L+C Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia\n\nL+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG002', 'title': 'Diabetics: L+E Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG003', 'title': 'Diabetics: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG004', 'title': 'Healthy: L+C Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia\n\nL+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG005', 'title': 'Healthy: L+C Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia\n\nL+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG006', 'title': 'Healthy: L+E Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG007', 'title': 'Healthy: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}], 'classes': [{'categories': [{'measurements': [{'value': '132.48', 'spread': '91.86', 'groupId': 'OG000'}, {'value': '173.27', 'spread': '70.44', 'groupId': 'OG001'}, {'value': '182.09', 'spread': '57.86', 'groupId': 'OG002'}, {'value': '195.35', 'spread': '68.99', 'groupId': 'OG003'}, {'value': '108.82', 'spread': '27.76', 'groupId': 'OG004'}, {'value': '155.59', 'spread': '60.75', 'groupId': 'OG005'}, {'value': '114.74', 'spread': '39.72', 'groupId': 'OG006'}, {'value': '172.91', 'spread': '68.93', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007'], 'groupDescription': 'In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 hours after local anesthesia injection', 'description': 'Time until cessation in soft tissue numbness', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Intensity of Intraoral Local Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '25', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetics: L+C Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia\n\nL+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG001', 'title': 'Diabetics: L+C Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia\n\nL+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG002', 'title': 'Diabetics: L+E Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG003', 'title': 'Diabetics: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG004', 'title': 'Healthy: L+C Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia\n\nL+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG005', 'title': 'Healthy: L+C Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia\n\nL+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG006', 'title': 'Healthy: L+E Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG007', 'title': 'Healthy: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 10 minutes after local anesthesia injection', 'description': 'Number of participants who reported values \\> 0 after pin-prick testing, using Visual Analogue Scale (VAS) and Numerical Rating Scale (NRS). VAS is represented by line 100 mm long, with one end marked with 0 and words "no pain" , while the other end is marked with 100 and words "the worst pain imanginable". VRS scale is represented by line 100 mm long, marked with numbers from 0 to 10, where 0 corresponds to "no pain", and 10 corresponds to "the worst pain imaginable". For both scales, higher scores represent worse outcomes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Baseline Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '25', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetics: L+C Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia\n\nL+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG001', 'title': 'Diabetics: L+C Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia\n\nL+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG002', 'title': 'Diabetics: L+E Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG003', 'title': 'Diabetics: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG004', 'title': 'Healthy: L+C Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia\n\nL+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG005', 'title': 'Healthy: L+C Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia\n\nL+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG006', 'title': 'Healthy: L+E Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG007', 'title': 'Healthy: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}], 'classes': [{'categories': [{'measurements': [{'value': '135.2759', 'spread': '16.69665611', 'groupId': 'OG000'}, {'value': '137.7333', 'spread': '18.43335308', 'groupId': 'OG001'}, {'value': '134.8125', 'spread': '18.66934265', 'groupId': 'OG002'}, {'value': '134.4667', 'spread': '17.69119729', 'groupId': 'OG003'}, {'value': '124.0455', 'spread': '11.07325079', 'groupId': 'OG004'}, {'value': '128.1818', 'spread': '15.49388931', 'groupId': 'OG005'}, {'value': '125', 'spread': '11.11918898', 'groupId': 'OG006'}, {'value': '126.5909', 'spread': '18.82322642', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 0 minutes', 'unitOfMeasure': 'milimeters of Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Systolic Blood Pressure at 10 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '25', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetics: L+C Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia\n\nL+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG001', 'title': 'Diabetics: L+C Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia\n\nL+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG002', 'title': 'Diabetics: L+E Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG003', 'title': 'Diabetics: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG004', 'title': 'Healthy: L+C Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia\n\nL+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG005', 'title': 'Healthy: L+C Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia\n\nL+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG006', 'title': 'Healthy: L+E Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG007', 'title': 'Healthy: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}], 'classes': [{'categories': [{'measurements': [{'value': '130.3793', 'spread': '18.81377496', 'groupId': 'OG000'}, {'value': '136.8333', 'spread': '14.27098173', 'groupId': 'OG001'}, {'value': '137.4375', 'spread': '19.73033934', 'groupId': 'OG002'}, {'value': '132.6', 'spread': '20.45858857', 'groupId': 'OG003'}, {'value': '120.8182', 'spread': '13.58092627', 'groupId': 'OG004'}, {'value': '122.5909', 'spread': '14.59503859', 'groupId': 'OG005'}, {'value': '125.8261', 'spread': '13.75979708', 'groupId': 'OG006'}, {'value': '125,4091', 'spread': '12.71541656', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10th minute', 'description': 'Systolic blood pressure values 5 minutes after local anesthesia injection', 'unitOfMeasure': 'milimeters of Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Systolic Blood Pressure at 15 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '25', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetics: L+C Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia\n\nL+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG001', 'title': 'Diabetics: L+C Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia\n\nL+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG002', 'title': 'Diabetics: L+E Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG003', 'title': 'Diabetics: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG004', 'title': 'Healthy: L+C Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia\n\nL+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG005', 'title': 'Healthy: L+C Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia\n\nL+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG006', 'title': 'Healthy: L+E Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG007', 'title': 'Healthy: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}], 'classes': [{'categories': [{'measurements': [{'value': '133.5862', 'spread': '13.51590925', 'groupId': 'OG000'}, {'value': '133.4667', 'spread': '14.12684735', 'groupId': 'OG001'}, {'value': '137.4688', 'spread': '19.28058421', 'groupId': 'OG002'}, {'value': '132.0667', 'spread': '17.89580957', 'groupId': 'OG003'}, {'value': '114.4545', 'spread': '11.89128241', 'groupId': 'OG004'}, {'value': '116.9091', 'spread': '12.78730431', 'groupId': 'OG005'}, {'value': '123.8696', 'spread': '13.61250878', 'groupId': 'OG006'}, {'value': '127.1818', 'spread': '18.58733917', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15th 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(1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG003', 'title': 'Diabetics: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG004', 'title': 'Healthy: L+C Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia\n\nL+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG005', 'title': 'Healthy: L+C Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia\n\nL+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'OG006', 'title': 'Healthy: L+E Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'OG007', 'title': 'Healthy: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours, 7 days', 'description': 'Postoperative paresthesia by clinical examination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diabetics: L+C Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia\n\nL+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'FG001', 'title': 'Diabetics: L+C Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia\n\nL+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'FG002', 'title': 'Diabetics: L+E Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'FG003', 'title': 'Diabetics: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'FG004', 'title': 'Healthy: L+C Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia\n\nL+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'FG005', 'title': 'Healthy: L+C Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia\n\nL+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'FG006', 'title': 'Healthy: L+E Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'FG007', 'title': 'Healthy: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '27'}, {'groupId': 'FG005', 'numSubjects': '26'}, {'groupId': 'FG006', 'numSubjects': '25'}, {'groupId': 'FG007', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '24'}, {'groupId': 'FG005', 'numSubjects': '25'}, {'groupId': 'FG006', 'numSubjects': '25'}, {'groupId': 'FG007', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants recruited between june 2013 and december 2015 among the patients of Clinic of Oral Surgery, Faculty of Dental Medicine, University of Belgrade'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}, {'value': '24', 'groupId': 'BG007'}, {'value': '220', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Diabetics: L+C Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia\n\nL+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'BG001', 'title': 'Diabetics: L+C Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia\n\nL+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'BG002', 'title': 'Diabetics: L+E Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'BG003', 'title': 'Diabetics: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'BG004', 'title': 'Healthy: L+C Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia\n\nL+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'BG005', 'title': 'Healthy: L+C Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia\n\nL+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)'}, {'id': 'BG006', 'title': 'Healthy: L+E Maxillary Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia\n\nL+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'BG007', 'title': 'Healthy: L+E Mandibular Anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia\n\nL+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}, {'value': '24', 'groupId': 'BG007'}, {'value': '220', 'groupId': 'BG008'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age between 18 and 65 years', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '126', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '94', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Serbia', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}, {'value': '24', 'groupId': 'BG007'}, {'value': '220', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass', 'classes': [{'categories': [{'measurements': [{'value': '78.72', 'spread': '11.19', 'groupId': 'BG000'}, {'value': '75.03', 'spread': '11.53', 'groupId': 'BG001'}, {'value': '85.84', 'spread': '14.76', 'groupId': 'BG002'}, {'value': '79.45', 'spread': '17.34', 'groupId': 'BG003'}, {'value': '79.50', 'spread': '15.22', 'groupId': 'BG004'}, {'value': '74.59', 'spread': '9.64', 'groupId': 'BG005'}, {'value': '71.01', 'spread': '12.08', 'groupId': 'BG006'}, {'value': '71.59', 'spread': '7.81', 'groupId': 'BG007'}, {'value': '76.90', 'spread': '8.42', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Plasma Glucose', 'classes': [{'categories': [{'measurements': [{'value': '8.12', 'spread': '3.01', 'groupId': 'BG000'}, {'value': '7.55', 'spread': '2.53', 'groupId': 'BG001'}, {'value': '9.66', 'spread': '4.02', 'groupId': 'BG002'}, {'value': '8.35', 'spread': '2.49', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'description': 'Available only for diabetic participants', 'unitOfMeasure': 'milimoles per liter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '6.83', 'spread': '4.59', 'groupId': 'BG000'}, {'value': '9.57', 'spread': '5.51', 'groupId': 'BG001'}, {'value': '9.77', 'spread': '7.62', 'groupId': 'BG002'}, {'value': '9.27', 'spread': '6.09', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycosilated Hemoglobin', 'classes': [{'categories': [{'measurements': [{'value': '7.42', 'spread': '1.25', 'groupId': 'BG000'}, {'value': '7.55', 'spread': '2.53', 'groupId': 'BG001'}, {'value': '7.63', 'spread': '1.72', 'groupId': 'BG002'}, {'value': '7.97', 'spread': '1.50', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percents', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of participants with modified diet', 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG004'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG005'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG006'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG007'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants on OHA therapy', 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG004'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG005'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG006'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG007'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants on insulin therapy', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG004'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG005'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG006'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG007'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG004'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG005'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG006'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG007'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Coronary Artery Disease', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG004'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG005'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG006'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG007'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Peripheral Neuropathy', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG004'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG005'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG006'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG007'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Intraoral Neuropathy', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG004'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG005'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG006'}, {'value': 'NA', 'comment': 'Available only for diabetic participants', 'groupId': 'BG007'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 256}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-22', 'studyFirstSubmitDate': '2015-02-04', 'resultsFirstSubmitDate': '2016-12-26', 'studyFirstSubmitQcDate': '2015-02-19', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-22', 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Intraoral Local Anesthesia', 'timeFrame': 'Up to 6 hours after local anesthesia injection', 'description': 'Time until cessation in soft tissue numbness'}, {'measure': 'Intensity of Intraoral Local Anesthesia', 'timeFrame': 'Up to 10 minutes after local anesthesia injection', 'description': 'Number of participants who reported values \\> 0 after pin-prick testing, using Visual Analogue Scale (VAS) and Numerical Rating Scale (NRS). VAS is represented by line 100 mm long, with one end marked with 0 and words "no pain" , while the other end is marked with 100 and words "the worst pain imanginable". VRS scale is represented by line 100 mm long, marked with numbers from 0 to 10, where 0 corresponds to "no pain", and 10 corresponds to "the worst pain imaginable". For both scales, higher scores represent worse outcomes.'}, {'measure': 'Baseline Systolic Blood Pressure', 'timeFrame': 'Baseline, 0 minutes'}, {'measure': 'Systolic Blood Pressure at 10 Minutes', 'timeFrame': '10th minute', 'description': 'Systolic blood pressure values 5 minutes after local anesthesia injection'}, {'measure': 'Systolic Blood Pressure at 15 Minutes', 'timeFrame': '15th minute', 'description': 'Systolic blood pressure values 10 minutes after local anesthesia injection'}, {'measure': 'Systolic Blood Pressure at 20 Minutes', 'timeFrame': '20th minute', 'description': 'Systolic blood pressure values 15 minutes after local anesthesia injection'}, {'measure': 'Systolic Blood Pressure at 35 Minutes', 'timeFrame': '35th minute', 'description': 'Systolic blood pressure values 30 minutes after local anesthesia injection'}, {'measure': 'Baseline Diastolic Blood Pressure', 'timeFrame': 'baseline, 0 minutes'}, {'measure': 'Diastolic Blood Pressure at 10 Minutes', 'timeFrame': '10th minute', 'description': 'Diastolic blood pressure values 5 minutes after local anesthesia injection'}, {'measure': 'Diastolic Blood Pressure at 15 Minutes', 'timeFrame': '15th minute', 'description': 'Diastolic blood pressure values 10 minutes after local anesthesia injection'}, {'measure': 'Diastolic Blood Pressure at 20 Minutes', 'timeFrame': '20th minute', 'description': 'Diastolic blood pressure values 15 minutes after local anesthesia injection'}, {'measure': 'Diastolic Blood Pressure at 35 Minutes', 'timeFrame': '35th minute', 'description': 'Diastolic blood pressure values 30 minutes after local anesthesia injection'}, {'measure': 'Baseline Values of Heart Rate', 'timeFrame': 'baseline, 0 minutes'}, {'measure': 'Heart Rate at 10 Minutes', 'timeFrame': '10th minute', 'description': 'Heart rate 5 minutes after local anesthesia injection, 10 minutes after baseline measurement'}, {'measure': 'Heart Rate at 15 Minutes', 'timeFrame': '15th minute', 'description': 'Heart rate 10 minutes after local anesthesia injection, 15 minutes after baseline measurement'}, {'measure': 'Heart Rate at 20 Minutes', 'timeFrame': '20th minute', 'description': 'Heart rate 15 minutes after local anesthesia injection, 20 minutes after baseline measurement'}, {'measure': 'Ceart Rate at 35 Minutes', 'timeFrame': '35th minute', 'description': 'Heart rate 30 minutes after local anesthesia injection, 35 minutes after baseline measurement'}, {'measure': 'Baseline Electrocardiogram', 'timeFrame': 'baseline, 0 minutes'}, {'measure': 'Electrocardiogram at 10 Minutes', 'timeFrame': '10th minute', 'description': 'ECG 5 minutes after local anesthesia injection, 10 minutes after baseline measurement'}, {'measure': 'Electrocardiogram at 15 Minutes', 'timeFrame': '15th minute', 'description': 'ECG 10 minutes after local anesthesia injection, 15 minutes after baseline measurement'}, {'measure': 'Electrocardiogram at 20 Minutes', 'timeFrame': '20th minute', 'description': 'ECG 15 minutes after local anesthesia injection, 20 minutes after baseline measurement'}], 'secondaryOutcomes': [{'measure': 'Onset of Intraoral Local Anesthesia', 'timeFrame': 'Up to 10 minutes, until subjective feeling of soft tissue numbnes', 'description': 'Evaluated by pin-prick after subjective feeling of soft tissue numbness appeared after local anesthesia injection'}, {'measure': 'Width of Anesthetic Field After Maxillary Infiltration Anesthesia', 'timeFrame': 'Up to 10 minutes after injection of local anesthesia', 'description': 'Soft tissue numbness area determined by pin-prick test after maxillary infiltration anesthesia. Not tested for mandibular ablock anesthesia.'}, {'measure': 'Postoperative Analgesia', 'timeFrame': 'up to 24 hours after tooth extraction', 'description': 'Number of participants who experienced postoperative pain, VAS, NRS'}, {'measure': 'Local Postoperative Complications', 'timeFrame': '24 hours, 7 days', 'description': 'Postoperative paresthesia by clinical examination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Local Anesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether 2% lidocaine (L) + clonidine (C) (15 mcg/ml) as a vasoconstrictor achieves efficient (equal or better parameters of intraoral local anesthesia in comparison to 2% lidocaine + epinephrine (E) (1:80 000)) and safe (stable cardiovascular parameters - systolic, diastolic, mean blood pressure and heart rate) intraoral local anesthesia in patients with Diabetes mellitus type 2.', 'detailedDescription': 'Patients with diabetes mellitus type 2, represent a risk for performing regional anesthesia techniques due to microvascular (microangiopathy, neuropathy) and macrovascular (hypertension, coronary heart disease) complications. There is evidence that local anesthetic toxicity may be increased in diabetic setting due to underlying neuropathy; while interaction of diabetic blood vessels with vasoconstrictors may be of importance because of microangiopathic changes. Lately, regional anesthesia protocol in general surgery for patients with diabetes mellitus was released, proposing reduction of local anesthetic concentration and avoiding epinephrine as vasoconstrictor.\n\nOral cavity tissues in diabetes mellitus also suffer from neuropathy (burning, paresthesia, teeth loss, temporomandibular dysfunction, xerostomia) and microangiopathy (periodontal disease, salivary gland dysfunction). Most widely used vasoconstrictor for intraoral local anesthesia, epinephrine, is an alpha- and beta- adrenergic agonist. Because of its beta-adrenergic effects, epinephrine could adversely affect cardiovascular function, especially in risk patients. There are data suggesting that intraoral local anesthesia obtained with 2% lidocaine with clonidine, selective alpha 2-adrenoceptor agonist as a vasoconstrictor, is characterized with significantly more stable cardiovascular parameters and similar parameters of local anesthesia with respect to lidocaine with epinephrine in healthy and hypertensive patients.\n\nWith regard to aforementioned, the aim of this randomized double-blind controlled clinical trial is to evaluate and compare efficacy and safety of intraoral local anesthesia obtained with 2% lidocaine (L) + clonidine (15 mcg/ml) (C) or 2% L + epinephrine (1:80 000) (E), comparing healthy and diabetes mellitus type 2 patients. Prior to tooth extraction, random allocation to one of four groups (L+C maxillary infiltration, L+C mandibular block, L+E maxillary infiltration and L+E mandibular block) is performed for diabetic (30 per group) and healthy (30 per group) patients. Parameters of local anesthesia (onset, duration, intensity, width of anesthetic field for maxillary infiltration), cardiovascular parameters (systolic, diastolic, mean arterial pressure; heart rate and electrocardiographic changes), quality of postoperative analgesia (assessed by Visual Analogue Scale, Numerical Rating Scale and number of consumed analgesics) and postoperative complications (infection, bleeding, paresthesia, delayed wound healing) are evaluated and compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participants: ASA I\n* Diabetic type 2 participants: ASA III (HbA1c level \\< 9%)\n* Required a single-root teeth indicated for non-complicated extraction\n* Dental diagnosis of periodontal disease, tooth fracture, chronic periapical lesion and root infection\n* Subjects give informed written consent\n\nExclusion Criteria:\n\n* Pregnancy and lactation\n* Allergy to used drugs and food\n* Hepatic and/or renal failure\n* ASA IV patients\n* Tobacco smokers\n* History of alcoholism and/or drug abuse and addiction'}, 'identificationModule': {'nctId': 'NCT02371759', 'acronym': 'LCIOADMT2', 'briefTitle': 'Lidocaine + Clonidine for Intraoral Anesthesia in Patients With Diabetes Mellitus Type 2', 'organization': {'class': 'OTHER', 'fullName': 'University of Belgrade'}, 'officialTitle': 'Efficacy and Safety of Intraoral Local Anesthesia by Lidocaine + Clonidine in Patients With Diabetes Mellitus Type 2', 'orgStudyIdInfo': {'id': 'UBelgrade 534/2'}, 'secondaryIdInfos': [{'id': '175021', 'type': 'OTHER_GRANT', 'domain': 'Ministry of Education, Science and Technological Development'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diabetics: L+C maxillary anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia', 'interventionNames': ['Drug: L+C maxillary anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'Diabetics: L+C mandibular anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia', 'interventionNames': ['Drug: L+C mandibular anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diabetics: L+E maxillary anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia', 'interventionNames': ['Drug: L+E maxillary anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diabetics: L+E mandibular anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia', 'interventionNames': ['Drug: L+E mandibular anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy: L+C maxillary anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia', 'interventionNames': ['Drug: L+C maxillary anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy: L+C mandibular anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia', 'interventionNames': ['Drug: L+C mandibular anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy: L+E maxillary anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia', 'interventionNames': ['Drug: L+E maxillary anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy: L+E mandibular anesthesia', 'description': 'Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia', 'interventionNames': ['Drug: L+E mandibular anesthesia']}], 'interventions': [{'name': 'L+C maxillary anesthesia', 'type': 'DRUG', 'description': 'Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)', 'armGroupLabels': ['Diabetics: L+C maxillary anesthesia', 'Healthy: L+C maxillary anesthesia']}, {'name': 'L+C mandibular anesthesia', 'type': 'DRUG', 'description': 'Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)', 'armGroupLabels': ['Diabetics: L+C mandibular anesthesia', 'Healthy: L+C mandibular anesthesia']}, {'name': 'L+E maxillary anesthesia', 'type': 'DRUG', 'description': 'Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)', 'armGroupLabels': ['Diabetics: L+E maxillary anesthesia', 'Healthy: L+E maxillary anesthesia']}, {'name': 'L+E mandibular anesthesia', 'type': 'DRUG', 'description': 'Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)', 'armGroupLabels': ['Diabetics: L+E mandibular anesthesia', 'Healthy: L+E mandibular anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'School of Dental Medicine, University of Belgrade', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'overallOfficials': [{'name': 'Dragica DM Stojic, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Dental Medicine, University of Belgrade'}, {'name': 'Bozidar M Brkovic, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Dental Medicine, University of Belgrade'}, {'name': 'Marija S Milic, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Dental Medicine, University of Belgrade'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Belgrade', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, DDS, MSc, PhD', 'investigatorFullName': 'Bozidar Brkovic, DDS, MSc, PhD, Professor', 'investigatorAffiliation': 'University of Belgrade'}}}}