Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-02-24 @ 5:05 AM
Study NCT ID:
NCT04248803
Status:
COMPLETED
Last Update Posted:
2025-10-17
First Post:
2020-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Gluma Desensitizer in Post-treatment Sensitivity in Posterior Composite
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C044372', 'term': 'Gluma'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'geethdeepika@gmail.com', 'phone': '9952331820', 'title': 'Dr Geeth Deepika', 'organization': 'TamilNadu MU'}, 'certainAgreement': {'otherDetails': 'The PIs of the current study have no sponsors. (Self-sponsored study)', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': '1. Limited generalizability owing to similar ethnicity and race among all the study participants.\n2. Limited reliability of subjective scales such as VAS.'}}, 'adverseEventsModule': {'timeFrame': 'The study began enrolling participants from February 6, 2020 to February 20, 2025. The adverse events were thoroughly examined for each participant who was enrolled in this clinical trial started from their baseline period at the end of 24 hours till their final visit at the end of 1 week. The last participant was recruited on February 13, 2025 and adverse events were examined with the study completion on February 20, 2025. The adverse events time frame for this study would be "1 Week".', 'eventGroups': [{'id': 'EG000', 'title': 'Total Etch Control Group', 'description': 'No gluma desensitizer application', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 0, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TE - GLUMA Application Prior to Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 0, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'TE - GLUMA Application After Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 0, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Self Etch Control Group', 'description': 'No gluma desensitizer application', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 0, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'SE - GLUMA Application Prior to Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 0, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'SE - GLUMA Application After Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 0, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Post-operative Sensitivity Having VAS Score >3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}, {'value': '84', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Etch (TE) Control Group', 'description': 'No gluma desensitizer application'}, {'id': 'OG001', 'title': 'TE - GLUMA Application After Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG002', 'title': 'TE - GLUMA Application Prior to Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG003', 'title': 'Self Etch (SE) Control Group', 'description': 'No gluma desensitizer application'}, {'id': 'OG004', 'title': 'SE - GLUMA Application Prior to Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG005', 'title': 'SE - GLUMA Application After Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'groupDescription': 'The sample size was estimated to be 504 using G Power software with 95% power and alpha value set to 0.05. The participants were randomly divided to 6 groups with randomizer.org. The statistical analysis was carried out using SPSS 23 software to compare the mean pain scores between the six study groups using kruskal Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'From the above mentioned non inferiority clinical trial it is hypothesized that GLUMA application will reduce postoperative sensitivity during dental restorative procedures.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'post-operative sensitivity is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '84 participants in each group were analyzed for post operative sensitivity using visual analogue scale (VAS) ranging from 1 -10 at the end of 24 hours.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Post-operative Sensitivity Having VAS Score >3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}, {'value': '84', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Etch (TE) Control Group', 'description': 'No gluma desensitizer application'}, {'id': 'OG001', 'title': 'TE - GLUMA Application After Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG002', 'title': 'TE - GLUMA Application Prior to Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG003', 'title': 'Self Etch (SE) Control Group', 'description': 'No gluma desensitizer application'}, {'id': 'OG004', 'title': 'SE - GLUMA Application Prior to Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG005', 'title': 'SE - GLUMA Application After Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours', 'description': 'post-operative sensitivity is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '84 participants in each group were analyzed for post operative sensitivity using VAS ranging from 1 - 10 at the end of 48 hours'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Post-operative Sensitivity Having VAS Score >3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}, {'value': '84', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Etch (TE) Control Group', 'description': 'No gluma desensitizer application'}, {'id': 'OG001', 'title': 'TE - GLUMA Application After Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG002', 'title': 'TE - GLUMA Application Prior to Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG003', 'title': 'Self Etch (SE) Control Group', 'description': 'No gluma desensitizer application'}, {'id': 'OG004', 'title': 'SE - GLUMA Application Prior to Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG005', 'title': 'SE - GLUMA Application After Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 week', 'description': 'post-operative sensitivity is evaluated using Visual Analog Scale(VAS) and cold spray VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '84 participants in each group were analyzed for post operative sensitivity using VAS ranging from 1 - 10 at the end of 1 week'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}, {'value': '84', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Etch (TE) Control Group', 'description': 'No gluma desensitizer application'}, {'id': 'OG001', 'title': 'TE - GLUMA Application After Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG002', 'title': 'TE - GLUMA Application Prior to Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG003', 'title': 'Self Etch (SE) Control Group', 'description': 'No gluma desensitizer application'}, {'id': 'OG004', 'title': 'SE - GLUMA Application Prior to Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG005', 'title': 'SE - GLUMA Application After Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Post operative sensitivity either stimulus based or spontaneous were analyzed using VAS ranging from 1 - 10 at the end of 24 hours'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}, {'value': '84', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Etch (TE) Control Group', 'description': 'No gluma desensitizer application'}, {'id': 'OG001', 'title': 'TE - GLUMA Application After Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG002', 'title': 'TE - GLUMA Application Prior to Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG003', 'title': 'Self Etch (SE) Control Group', 'description': 'No gluma desensitizer application'}, {'id': 'OG004', 'title': 'SE - GLUMA Application Prior to Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG005', 'title': 'SE - GLUMA Application After Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours', 'description': 'post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Post operative sensitivity either stimulus based or spontaneous were analyzed using VAS ranging from 1 - 10 at the end of 48 hours'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}, {'value': '84', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Etch (TE) Control Group', 'description': 'No gluma desensitizer application'}, {'id': 'OG001', 'title': 'TE - GLUMA Application After Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG002', 'title': 'TE - GLUMA Application Prior to Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG003', 'title': 'Self Etch (SE) Control Group', 'description': 'No gluma desensitizer application'}, {'id': 'OG004', 'title': 'SE - GLUMA Application Prior to Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'OG005', 'title': 'SE - GLUMA Application After Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 week', 'description': 'post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Post operative sensitivity either stimulus based or spontaneous were analyzed using VAS ranging from 1 - 10 at the end of 1 week'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Total Etch (TE) Control Group', 'description': 'No gluma desensitizer application'}, {'id': 'FG001', 'title': 'TE - GLUMA Application After Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'FG002', 'title': 'TE - GLUMA Application Prior to Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'FG003', 'title': 'Self Etch (SE) Control Group', 'description': 'No gluma desensitizer application'}, {'id': 'FG004', 'title': 'SE - GLUMA Application Prior to Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'FG005', 'title': 'SE - GLUMA Application After Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '91'}, {'groupId': 'FG002', 'numSubjects': '91'}, {'groupId': 'FG003', 'numSubjects': '91'}, {'groupId': 'FG004', 'numSubjects': '91'}, {'groupId': 'FG005', 'numSubjects': '91'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '84'}, {'groupId': 'FG002', 'numSubjects': '84'}, {'groupId': 'FG003', 'numSubjects': '84'}, {'groupId': 'FG004', 'numSubjects': '84'}, {'groupId': 'FG005', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Participants were recruited from the Out Patient Department of Conservative Dentistry and Endodontics with a chief complaint of decayed tooth during the period from 2020 to 2024. The first patient was enrolled on February 6,2020 and the last patient was enrolled on February 20, 2025', 'preAssignmentDetails': 'Of 570 enrolled participants, out of these 546 met the inclusion criteria and were randomized to study groups'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}, {'value': '91', 'groupId': 'BG005'}, {'value': '546', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Etch (TE)Control Group', 'description': 'No gluma desensitizer application'}, {'id': 'BG001', 'title': 'TE - GLUMA Application Prior to Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'BG002', 'title': 'TE - GLUMA Application After Acid Etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'BG003', 'title': 'Self Etch (SE) Control Group', 'description': 'No gluma desensitizer application'}, {'id': 'BG004', 'title': 'SE - GLUMA Application Prior to Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'BG005', 'title': 'SE - GLUMA Application After Acid Etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent\n\nGLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '8', 'groupId': 'BG000'}, {'value': '28', 'spread': '8', 'groupId': 'BG001'}, {'value': '27', 'spread': '8', 'groupId': 'BG002'}, {'value': '28', 'spread': '9', 'groupId': 'BG003'}, {'value': '30', 'spread': '8', 'groupId': 'BG004'}, {'value': '27', 'spread': '7', 'groupId': 'BG005'}, {'value': '28.37', 'spread': '7.97', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '183', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}, {'value': '363', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', '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'}]}, {'title': 'Asian', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}, {'value': '91', 'groupId': 'BG005'}, {'value': '546', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', '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'}]}, {'title': 'Black or African American', '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'}]}, {'title': 'White', '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'}]}, {'title': 'More than one race', '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'}]}, {'title': 'Unknown or Not Reported', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All participants belong to the Indian Subcontinent (Asian).', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'India', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}, {'value': '91', 'groupId': 'BG005'}, {'value': '546', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Visual Analogue Scale (VAS)', 'classes': [{'categories': [{'measurements': [{'value': '0.86', 'spread': '1.67', 'groupId': 'BG000'}, {'value': '1.72', 'spread': '2.15', 'groupId': 'BG001'}, {'value': '1.16', 'spread': '2.07', 'groupId': 'BG002'}, {'value': '1.88', 'spread': '2.25', 'groupId': 'BG003'}, {'value': '0.63', 'spread': '1.05', 'groupId': 'BG004'}, {'value': '2.11', 'spread': '2.40', 'groupId': 'BG005'}, {'value': '1.39', 'spread': '1.93', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': "A Visual Analogue Scale (VAS) is one of the pain rating scale ranging from 1 to 10 the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. From the patient's perspective, this spectrum appears continuous. often categorized as none (VAS=0), mild (VAS=1-3), moderate (VAS=4-6)and severe (VAS=7-10). VAS is widely used due to its simplicity and adaptability to a broad range of populations and settings.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'A total of 570 participants were enrolled for the study of which only 546 participants met the inclusion criteria which is been described earlier. The participants who met the inclusion criteria were randomly assigned to 6 study groups with 91 participants in each group'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-09-02', 'size': 844154, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-04T03:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 570}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2020-01-28', 'resultsFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2020-01-29', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-30', 'studyFirstPostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Post-operative Sensitivity Having VAS Score >3', 'timeFrame': '24 hours', 'description': 'post-operative sensitivity is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe'}, {'measure': 'Number of Participants With Post-operative Sensitivity Having VAS Score >3', 'timeFrame': '48 hours', 'description': 'post-operative sensitivity is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe'}, {'measure': 'Number of Participants With Post-operative Sensitivity Having VAS Score >3', 'timeFrame': '1 week', 'description': 'post-operative sensitivity is evaluated using Visual Analog Scale(VAS) and cold spray VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3', 'timeFrame': '24 hours', 'description': 'post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe'}, {'measure': 'Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3', 'timeFrame': '48 hours', 'description': 'post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe'}, {'measure': 'Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3', 'timeFrame': '1 week', 'description': 'post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sensitivity, Tooth']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of Gluma desensitizer in controlling immediate post-treatment sensitivity in posterior occlusal composite restorations.', 'detailedDescription': 'The primary objective of this study is to observe the effect of gluma desensitizer application in controlling the post-treatment sensitivity in posterior occlusal composite restoration in molar teeth using 2 adhesive bonding strategies.\n\nThe secondary objective is to evaluate the difference in the post-treatment sensitivity on application of Gluma desensitizer either prior to or after acid etching.\n\nThe different adhesive gluma desensitizer application groups are randomly divided into 6 groups,\n\n1. Total etch control group (No gluma desensitizer application)\n2. Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching\n3. Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching\n4. Self etch control group (No gluma desensitizer application)\n5. Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching\n6. Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Occlusal cavitated caries in maxillary and mandibular first and second molars\n\nExclusion Criteria:\n\n* Occlusal caries with axial or proximal extension\n* Teeth with periodontal treatment within last three months\n* Teeth with cracks\n* Teeth to be taken as abutment for prosthesis\n* Patients with psychiatric treatment\n* Patients in orthodontic treatment or going to need orthodontic treatment\n* Patients under dentin hypersensitivity or using desensitizer treatment\n* Patients not willing for post treatment follow up\n* Patients having any other teeth with pain or sensitivity symptoms\n* Caries excavation with pulp exposure and post treatment sensitivity due to occusal interference in restoration'}, 'identificationModule': {'nctId': 'NCT04248803', 'briefTitle': 'Evaluation of Gluma Desensitizer in Post-treatment Sensitivity in Posterior Composite', 'organization': {'class': 'OTHER', 'fullName': 'Tamil Nadu Dr.M.G.R.Medical University'}, 'officialTitle': 'Efficacy of Gluma Desensitizer in Controlling the Immediate Post-treatment Sensitivity in Etch-and-rinse and Self-etch Adhesive Bonded Occlusal Composite Restorations', 'orgStudyIdInfo': {'id': 'CSICDSR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Total etch control group', 'description': 'No gluma desensitizer application'}, {'type': 'EXPERIMENTAL', 'label': 'TE - GLUMA application prior to acid etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent', 'interventionNames': ['Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent']}, {'type': 'EXPERIMENTAL', 'label': 'TE - GLUMA application after acid etching', 'description': 'TE- Total Etch GLUMA - Desensitizing agent', 'interventionNames': ['Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent']}, {'type': 'NO_INTERVENTION', 'label': 'Self etch control group', 'description': 'No gluma desensitizer application'}, {'type': 'EXPERIMENTAL', 'label': 'SE - GLUMA application prior to acid etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent', 'interventionNames': ['Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent']}, {'type': 'EXPERIMENTAL', 'label': 'SE - GLUMA application after acid etching', 'description': 'SE - Self Etch GLUMA - Desensitizing agent', 'interventionNames': ['Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent']}], 'interventions': [{'name': 'GLUMA (Kulzer GmbH, Germany) desensitizing agent', 'type': 'OTHER', 'description': 'GLUMA desensitizer is used to reduce tooth sensitivity', 'armGroupLabels': ['SE - GLUMA application after acid etching', 'SE - GLUMA application prior to acid etching', 'TE - GLUMA application after acid etching', 'TE - GLUMA application prior to acid etching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '625 001', 'city': 'Madurai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'CSI College of Dental Sciences and Research', 'geoPoint': {'lat': 9.919, 'lon': 78.11953}}], 'overallOfficials': [{'name': 'GEETH DEEPIKA, MDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TN MGR MEDICAL UNIVERSITY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tamil Nadu Dr.M.G.R.Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Geeth Deepika', 'investigatorAffiliation': 'Tamil Nadu Dr.M.G.R.Medical University'}}}}