Alendronate Compared to Metformin in Chronic Periodontitis

Government Dental College and Research Institute, Bangalore108 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

108

Conditions

Chronic Periodontitis

Interventions

SRP plus Placebo GelDRUG

After SRP, placebo gel was delivered subgingivally into the pocket

SRP plus Alendronate gelDRUG

Alendronate (ALN) After SRP, ALN gel was delivered subgingivally into the pocket

SRP plus Metformin gelDRUG

Metformin (MF) After SRP, MF gel was delivered subgingivally into the pocket

Eligibility

Sex: ALLMin age: 25 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

bone fill

amount of bone fill from baseline to 9 months

Time frame: baseline to 9 months

Secondary Outcomes

Relative vertical clinical attachment level

change in Relative vertical clinical attachment level baseline to 9 months

Time frame: baseline to 9 months

probing depth

change in probing depth from baseline to 9 months

Time frame: baseline to 9 months

Data from ClinicalTrials.gov

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