Alendronate Compared to Metformin in Chronic Periodontitis

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

Detailed Description
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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

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

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: SRP plus Placebo Gel
* Drug: SRP plus Alendronate gel
* Drug: SRP plus Metformin gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alendronate, metformin