Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-25 @ 5:45 PM
Study NCT ID:
NCT02461667
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2015-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alendronate Compared to Metformin in Chronic Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-31', 'studyFirstSubmitDate': '2015-05-19', 'studyFirstSubmitQcDate': '2015-05-31', 'lastUpdatePostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bone fill', 'timeFrame': 'baseline to 9 months', 'description': 'amount of bone fill from baseline to 9 months'}], 'secondaryOutcomes': [{'measure': 'Relative vertical clinical attachment level', 'timeFrame': 'baseline to 9 months', 'description': 'change in Relative vertical clinical attachment level baseline to 9 months'}, {'measure': 'probing depth', 'timeFrame': 'baseline to 9 months', 'description': 'change in probing depth from baseline to 9 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['alendronate, metformin'], 'conditions': ['Chronic Periodontitis']}, 'descriptionModule': {'briefSummary': 'This is a 9 month randomised controlled clinical comparing the clinical efficacy of 1%metformin and 1%alendronate in chronic periodontitis subjects.', 'detailedDescription': 'ABSTRACT Background: Since Metformin (MF) induces osteoblast growth and differentiation while Alendronate (ALN) act as an antiosteolytic agent. The aim of the present study is to evaluate and compare the efficacy of 1% ALN and 1% MF gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of intrabony defects in patients with chronic periodontitis.\n\nMethods:\n\nThe study had 3 groups comprising of ninety subjects, divided into three groups 1% MF with SRP, 1% ALN with SRP and placebo gel with SRP. Clinical parameters (plaque index (PI), modified sulcus bleeding index (mSBI), probing pocket depth (PPD), and clinical attachment level (CAL) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the subjects were systemically healthy\n* subjects with sites having CAL ≥ 3 mm, PPD ≥ 5 mm,\n* vertical bone loss ≥ 3 mm on intraoral periapical radiographs (IOPA) and\n* subjects with no history of periodontal intervention in the last 6 months.\n\nExclusion Criteria:\n\n* patients with systemic diseases like cardiovascular disease\n* diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.\n* pregnant/lactating females\n* tobacco users\n* alcoholics\n* patients with unsatisfactory oral hygiene (plaque index greater than 1.5)\n* teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility\n* Furthermore, patients allergic to Metformin and alendronate or those taking Metformin and alendronate systemically were excluded.'}, 'identificationModule': {'nctId': 'NCT02461667', 'briefTitle': 'Alendronate Compared to Metformin in Chronic Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Government Dental College and Research Institute, Bangalore'}, 'officialTitle': 'Comparative Evaluation of Subgingivally Delivered 1% Metformin and 1% Alendronate Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'GDCRI/ACM/PG/PhD/2/2013-2014G'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket', 'interventionNames': ['Drug: SRP plus Placebo Gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'description': 'SRP plus Metformin SRP was done for all the subjects. metformin was delivered in the pocket subgingivally', 'interventionNames': ['Drug: SRP plus Metformin gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alendronate', 'description': 'SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally', 'interventionNames': ['Drug: SRP plus Alendronate gel']}], 'interventions': [{'name': 'SRP plus Placebo Gel', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'After SRP, placebo gel was delivered subgingivally into the pocket', 'armGroupLabels': ['placebo']}, {'name': 'SRP plus Alendronate gel', 'type': 'DRUG', 'otherNames': ['Alendronate gel'], 'description': 'Alendronate (ALN) After SRP, ALN gel was delivered subgingivally into the pocket', 'armGroupLabels': ['Alendronate']}, {'name': 'SRP plus Metformin gel', 'type': 'DRUG', 'otherNames': ['Metformin gel'], 'description': 'Metformin (MF) After SRP, MF gel was delivered subgingivally into the pocket', 'armGroupLabels': ['Metformin']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Government Dental College and Research Institute, Bangalore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and head, Dept. of Periodontology', 'investigatorFullName': 'Dr. A R Pradeep', 'investigatorAffiliation': 'Government Dental College and Research Institute, Bangalore'}}}}