Alendronate Compared to Metformin in Chronic Periodontitis

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: SRP plus Placebo Gel; Drug: SRP plus Alendronate gel; Drug: SRP plus Metformin gel

• Registration Number: NCT02461667
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief Summary

This is a 9 month randomised controlled clinical comparing the clinical efficacy of 1%metformin and 1%alendronate in chronic periodontitis subjects.

Detailed Description

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.

Methods:

The 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

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-05
• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-31
• Last Update Submitted: 2015-05-31
• Study First Posted: 2015-06-03
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• All the subjects were systemically healthy
• subjects with sites having CAL ≥ 3 mm, PPD ≥ 5 mm,
• vertical bone loss ≥ 3 mm on intraoral periapical radiographs (IOPA) and
• subjects with no history of periodontal intervention in the last 6 months.

Exclusion Criteria

• patients with systemic diseases like cardiovascular disease
• diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.
• pregnant/lactating females
• tobacco users
• alcoholics
• patients with unsatisfactory oral hygiene (plaque index greater than 1.5)
• teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility
• Furthermore, patients allergic to Metformin and alendronate or those taking Metformin and alendronate systemically were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	SRP plus Placebo Gel	SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket
Alendronate	SRP plus Alendronate gel	SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally
Metformin	SRP plus Metformin gel	SRP plus Metformin SRP was done for all the subjects. metformin was delivered in the pocket subgingivally

Primary Outcome Measures

Name	Time	Method
bone fill	baseline to 9 months	amount of bone fill from baseline to 9 months

Secondary Outcome Measures

Name	Time	Method
Relative vertical clinical attachment level	baseline to 9 months	change in Relative vertical clinical attachment level baseline to 9 months
probing depth	baseline to 9 months	change in probing depth from baseline to 9 months