Alendronate Compared to Metformin in Chronic Periodontitis

Comparative Evaluation of Subgingivally Delivered 1% Metformin and 1% Alendronate Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: SRP plus Placebo Gel; Drug: SRP plus Metformin gel; Drug: SRP plus Alendronate gel

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket	Drug: SRP plus Placebo Gel; After SRP, placebo gel was delivered subgingivally into the pocket; Other Names: Placebo
Active Comparator: Metformin; SRP plus Metformin SRP was done for all the subjects. metformin was delivered in the pocket subgingivally	Drug: SRP plus Metformin gel; Metformin (MF) After SRP, MF gel was delivered subgingivally into the pocket; Other Names: Metformin gel
Active Comparator: Alendronate; SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally	Drug: SRP plus Alendronate gel; Alendronate (ALN) After SRP, ALN gel was delivered subgingivally into the pocket; Other Names: Alendronate gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone fill	amount of bone fill from baseline to 9 months	baseline to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative vertical clinical attachment level	change in Relative vertical clinical attachment level baseline to 9 months	baseline to 9 months
probing depth	change in probing depth from baseline to 9 months	baseline to 9 months

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: May 31, 2015
• First Posted (Estimate): June 3, 2015

Study Record Updates

• Last Update Posted (Estimate): June 3, 2015
• Last Update Submitted That Met QC Criteria: May 31, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: alendronate, metformin
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Hypoglycemic Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Metformin; Alendronate
• Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2013-2014G