Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-25 @ 10:59 PM
Study NCT ID:
NCT03087266
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2017-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute-phase Response & Periodontal Treatment in Diabetes Affected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'single-centre randomized controlled clinical trial with a 3- month follow-up'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2017-03-07', 'studyFirstSubmitQcDate': '2017-03-15', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels C-Reactive Protein', 'timeFrame': 'Baseline, 24 hours and 3 months after treatment', 'description': 'Changes in C reactive protein (CRP). Unit of measure: mg/L'}], 'secondaryOutcomes': [{'measure': 'Full Mouth Plaque Score (FMPS)', 'timeFrame': 'Baseline and 3 months after treatment', 'description': 'Changes in FMPS. Unit of Measure: %'}, {'measure': 'Full Mouth Bleeding Score (FMBS)', 'timeFrame': 'Baseline and 3 months after treatment', 'description': 'Changes in FMBS. Unit of Measure: %'}, {'measure': 'Pocket probing depth (PPD)', 'timeFrame': 'Baseline and 3 months after treatment', 'description': 'Changes in PPD. Unit of measure: mm'}, {'measure': 'Clinical attachment level (CAL)', 'timeFrame': 'Baseline and 3 months after treatment', 'description': 'Changes in CAL. Unit of measure: mm'}, {'measure': 'Recession of the gingival margin (REC)', 'timeFrame': 'Baseline and 3 months after treatment', 'description': 'Changes in REC. Unit of measure: mm'}, {'measure': 'Triglycerides', 'timeFrame': 'Baseline, 24 hours and 3 months after treatment', 'description': 'Changes in triglycerides. Unit of measure: mmol/L'}, {'measure': 'Low-density lipoprotein (LDL)', 'timeFrame': 'Baseline, 24 hours and 3 months after treatment', 'description': 'Changes in LDL. Unit of measure: mmol/L'}, {'measure': 'High-density lipoprotein (HDL)', 'timeFrame': 'Baseline, 24 hours and 3 months after treatment', 'description': 'Changes in HDL. Unit of measure: mmol/L'}, {'measure': 'Cholesterol', 'timeFrame': 'Baseline, 24 hours and 3 months after treatment', 'description': 'Changes in total cholesterol, Unit of measure: mmol/L'}, {'measure': 'Glycemia', 'timeFrame': 'Baseline, 24 hours and 3 months after treatment', 'description': 'Changes in blood glucose level. Unit of measure: mg/dl'}, {'measure': 'Glycated Haemoglobin', 'timeFrame': 'Baseline, 24 hours and 3 months after treatment', 'description': 'Changes in Glycated haemoglobin. Unit of measure: mmol/mol'}, {'measure': 'Insulin', 'timeFrame': 'Baseline, 24 hours and 3 months after treatment', 'description': 'Changes in Insulin level'}, {'measure': 'Systolic Blood Pressure (SBP)', 'timeFrame': 'Baseline, 24 hours and 3 months after treatment', 'description': 'Changes in SBP Unit of measure: mmHg'}, {'measure': 'Diastolic Blood Pressure (DBP)', 'timeFrame': 'Baseline, 24 hours and 3 months after treatment', 'description': 'Changes in DBP. Unit of measure: mmHg'}, {'measure': 'Endothelial Function', 'timeFrame': 'Baseline, 24 hours and 3 months after treatment', 'description': 'Measures of endothelial function taken through Flow-Mediated dilation. Unit of Measure: %'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis', 'Diabetes']}, 'referencesModule': {'references': [{'pmid': '36517997', 'type': 'DERIVED', 'citation': 'Graziani F, Gennai S, Marruganti C, Peric M, Ghiadoni L, Marhl U, Petrini M. Acute-phase response following one-stage full-mouth versus quadrant non-surgical periodontal treatment in subjects with comorbid type 2 diabetes: A randomized clinical trial. J Clin Periodontol. 2023 Apr;50(4):487-499. doi: 10.1111/jcpe.13760. Epub 2023 Jan 22.'}]}, 'descriptionModule': {'briefSummary': 'Thirty-eight periodontitis- and diabetes-affected subjects will be randomly allocated to non surgical periodontal treatment with either Full-Mouth Approach (FM-SRP) or Quadrant approach (Q-SRP).\n\nPatients will be seen one day and three months (study completion) after treatment. The 24 hours appointment will be occurring after the entire completion of the FM-SRP or the first quadrant of the Q-SRP. In the latter group other sessions of treatment will be performed within the following 3 weeks.\n\nAt baseline, 24 hours and three months, anthropometric, inflammatory and endothelial parameters will be collected. Periodontal parameters will be checked at baseline and at three months.\n\nMain outcome of the study is the level of C-reactive protein 24 hours after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients affected by Periodontal disease\n* 20% of periodontal pockets of the entire dentition\n* 20% bleeding on probing of the entire dentition\n* documented radiographic bone loss\n* Diagnosis of Diabetes Type 2 as measured through international standards\n\nExclusion Criteria:\n\n* age younger than 18 years and older than 80 years\n* pregnant or lactating females\n* females using contraceptive methods\n* need of antibiotic coverage for periodontal treatment\n* previous periodontal treatment in the last 6 months.'}, 'identificationModule': {'nctId': 'NCT03087266', 'acronym': 'PERIO-DIA', 'briefTitle': 'Acute-phase Response & Periodontal Treatment in Diabetes Affected Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Pisa'}, 'officialTitle': 'Acute-phase Response Following Full-mouth Versus Quadrant Non-surgical Periodontal Treatment in Diabetes-affected Subjects: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '3399/11_A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Full- Mouth Scaling and Root Planing', 'description': 'FM-SRP Non-surgical periodontal treatment will be performed in all dentition within 24 hours.', 'interventionNames': ['Procedure: FM-SRP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Quadrant Scaling and Root Planing', 'description': 'Q-SRP Non-surgical periodontal treatment will be performed in all dentition subdivided in four appointments. Each appointment will be performed with one week interval. In each appointment only a "quadrant" of the dentition will be instrumented.', 'interventionNames': ['Procedure: Q-SRP']}], 'interventions': [{'name': 'FM-SRP', 'type': 'PROCEDURE', 'description': 'Non surgical periodontal treatment performed in all dentition within 1-2 appointments in a 24 hour time frame.', 'armGroupLabels': ['Full- Mouth Scaling and Root Planing']}, {'name': 'Q-SRP', 'type': 'PROCEDURE', 'description': 'Non surgical periodontal treatment performed in 4 sessions comprising of a quadrant (1/4) of the dentition each. Performed in 3 weeks time frame.', 'armGroupLabels': ['Quadrant Scaling and Root Planing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56126', 'city': 'Pisa', 'country': 'Italy', 'facility': 'University Hospital of Pisa', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}], 'overallOfficials': [{'name': 'Filippo Graziani, DDS, MClinDent, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pisa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pisa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Periodontology', 'investigatorFullName': 'Filippo Graziani, DDS MClinDent PhD', 'investigatorAffiliation': 'University of Pisa'}}}}