Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-01-05 @ 12:23 AM
Study NCT ID:
NCT02048761
Status:
UNKNOWN
Last Update Posted:
2014-03-03
First Post:
2014-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Locally Delivered 1% Metformin Gel in the Treatment of Intrabony Defects in Chronic Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-28', 'studyFirstSubmitDate': '2014-01-23', 'studyFirstSubmitQcDate': '2014-01-28', 'lastUpdatePostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Defect depth reduction', 'timeFrame': 'Baseline to 6 months', 'description': 'The primary outcome of the study is to determine the defect depth reduction by 1% metformin gel radio-graphically and compare the outcome with control group.'}], 'secondaryOutcomes': [{'measure': 'Probing depth', 'timeFrame': 'Baseline to 6 months', 'description': 'Probing depth is measured from baseline to 3 months and 6 months in both control and test group.'}, {'measure': 'Clinical attachment level', 'timeFrame': 'Baseline to 6 months', 'description': 'Clinical attachment level is measured from baseline to 3 months and 6 months in both control and test group.'}, {'measure': 'Modified sulcular bleeding index', 'timeFrame': 'Baseline to 6 months', 'description': 'Modified sulcular bleeding index is measured from baseline to 3 months and 6 months in both control and test group.'}, {'measure': 'Plaque index', 'timeFrame': 'Baseline to 6 months', 'description': 'Full mouth and site specific plaque index is measured from baseline to 3 months and 6 months in both control and test group.'}]}, 'conditionsModule': {'conditions': ['Intrabony Defects in Chronic Periodontitis']}, 'descriptionModule': {'briefSummary': 'This study was designed as a randomized, controlled clinical trial to evaluate the efficacy of 1% MF gel as local drug delivery in adjunct to SRP for the treatment of intrabony defects in chronic periodontitis in comparison with placebo gel.', 'detailedDescription': 'Background: Metformin (MF) belonging to the class biguanide, is a first-line therapy for type 2 diabetes mellitus, and is one of the most commonly prescribed oral hypoglycemic drug worldwide. MF has shown to posses bone forming and bone sparring actions. The present study was designed to investigate effectiveness of MF, 1 % in an indigenously prepared biodegradable controlled-release gel as, as an adjunct to scaling and root planing (SRP) in treatment of chronic periodontitis subjects with intrabony defects.\n\nMaterials and Methods: Sixty five subjects were categorized into two treatment groups: SRP plus 1% MF and SRP plus placebo. Clinical parameters were recorded at baseline and at 3 and 6 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL). At baseline and after 6 months, radiologic assessment of intrabony defect (IBD) fill was done using computer-aided software.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemically healthy subjects\n* Sites with probing depth (PD) ≥5 mm\n* Clinical attachment level (CAL) ≥4 mm\n* Vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included\n\nExclusion Criteria:\n\n* Patients with known systemic disease\n* Known or suspected allergy to the MF/ biguanide group\n* Patients on systemic MF or other oral antidiabetic therapy\n* Patients with aggressive periodontitis\n* Patients with diabetes\n* Use of tobacco in any form\n* Alcoholism\n* Immunocompromised patients\n* Pregnant or lactating females'}, 'identificationModule': {'nctId': 'NCT02048761', 'briefTitle': 'Locally Delivered 1% Metformin Gel in the Treatment of Intrabony Defects in Chronic Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Government Dental College and Research Institute, Bangalore'}, 'officialTitle': 'Locally Delivered 1% Metformin Gel in the Treatment of Intrabony Defects in Subjects With Chronic Periodontitis : A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'GDCRI/ACM/PG/PhD/2013-14/B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'After debridement, placebo gel was applied into the periodontal pockets with a syringe and a blunt canula.', 'interventionNames': ['Drug: Placebo gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1% Metformin', 'description': 'After debridement, 1% Metformin gel was applied into the periodontal pockets with a syringe and a blunt canula.', 'interventionNames': ['Drug: 1 % Metformin gel']}], 'interventions': [{'name': 'Placebo gel', 'type': 'DRUG', 'description': 'After debridement, a single dose of the placebo gel was applied into the periodontal pockets with a syringe and a blunt canula', 'armGroupLabels': ['Placebo Group']}, {'name': '1 % Metformin gel', 'type': 'DRUG', 'description': 'After debridement, 1% Metformin gel gel was applied into the periodontal pockets with a syringe and a blunt canula.', 'armGroupLabels': ['1% Metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560002', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Government Dental College and Research Institute', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'overallOfficials': [{'name': 'A R Pradeep, M.D.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Govt Dental College & Research Inst, Bangalore.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Government Dental College and Research Institute, Bangalore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. A R Pradeep', 'investigatorAffiliation': 'Government Dental College and Research Institute, Bangalore'}}}}