Comparison of Alendronate With Atorvastatin in Chronic Periodontitis

Study Overview
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Brief Summary
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The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of two local drug delivery systems containing 1% ALN gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.

Detailed Description
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Background: Alendronate and Atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of 1% ALN and 1.2% ATV gel as a local drug delivery system in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis. Methods: A total of 90 intrabony defects were treated with either1%ALN, 1.2% ATV or placebo gel. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth [PD], 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% Alendronate Versus 1.2% Atorvastatin 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 and Placebo gel
* Drug: SRP and Atorvastatin
* Drug: SRP and Alendronate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included Exclusion Criteria: Patients with a known systemic disease; known or suspected allergy to the ALN/bisphosphonate group and ATV/statin group; on systemic ALN/bisphosphonate and therapy ATV/statin group; with aggressive periodontitis; who used tobacco in any form; alcoholics; immunocompromised patients; and pregnant or lactating females were excluded from the study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket | Drug: SRP and Placebo gel<br>* After SRP, placebo gel was delivered subgingivally into the pocket<br>|
| Active Comparator: Atorvastatin group<br>SRP plus Atorvastatin SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally | Drug: SRP and Atorvastatin<br>* After SRP, Atorvastatin gel was delivered subgingivally into the pocket<br>|
| Active Comparator: Alendronate Group<br>Alendronate SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally | Drug: SRP and Alendronate<br>* After SRP, Alendronate gel was delivered subgingivally into the pocket<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in defect depth reduction from baseline to 6 months and from baseline to 9 months | Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval | Baseline to 6 months and Baseline to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque index | Plaque index will be measured at 3, 6 and 9 months | 3,6 and 9 months | 
| Modified sulcus bleeding index | Modified sulcus bleeding index will be measured at 3, 6 and 9 months | 3,6 and 9 months] | 
| Probing pocket depth | Probing pocket depth will be measured at 3, 6 and 9 months | 3,6 and 9 months] | 
| Clinical attachment level | Clinical attachment level will be measured at 3, 6 and 9 months | 3,6 and 9 months] |