Alendronate Compared to Metformin in Chronic Periodontitis

Condition(s) targeted: Chronic Periodontitis

Intervention: SRP plus Placebo Gel (Drug); SRP plus Alendronate gel (Drug); SRP plus Metformin gel (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Government Dental College and Research Institute, Bangalore

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

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: bone fill

Secondary outcome:

Relative vertical clinical attachment level

probing depth

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

Minimum age: 25 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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.

Starting date: July 2014
Last updated: May 31, 2015