Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects

Study Overview
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Brief Summary
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ABSTARCT Background: Atorvastatin is an inhibitor of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. Lately, it has shown to have anti-inflammatory and bone stimulatory effects. The aim of the current study is to explore the effectiveness of 1.2% atorvastatin (ATV) as an adjunct to scaling and root planning (SRP) in the treatment of mandibular degree II furcation defects. Method: A total of sixty subjects were randomly assigned to two treatment groups. 1. SRP plus placebo gel 2. SRP plus 1.2% ATV gel. Clinical parameters like probing depth (PD), relative vertical clinical attachment level (RVCAL) , relative horizontal clinical attachment level (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index were recorded at baseline and then at 3, 6 and 9 months. The radiological assessment of bone defect fill was done at 6 and 9 months, using a computer-aided software.

Detailed Description
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Two groups were made. One was delivered with ATV after SRP, the other was delivered with placebo gel after SRP.

Official Title
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Clinical Efficacy of Subgingivally Delivered Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial .

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: Atorvastatin (ATV)
* Drug: Placebo Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lower first molars demonstrating a probing pocket depth of 5 mm and horizontal probing depth of 3 mm following phase 1 therapy, with furcation defects (degree II) present bucally in asymptomatic, vital lower first molars, with a furcation radiolucency on a periapical radiograph of the molars. 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 ATV or other statins or those taking ATV/other statins systemically were excluded.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 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: SRP plus placebo<br>SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket | Drug: Placebo Gel<br>* After SRP, placebo gel was delivered subgingivally into the pocket<br>|
| Active Comparator: SRP plus Atorvastatin<br>SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally | Drug: Atorvastatin (ATV)<br>* After SRP, ATV gel was delivered subgingivally into the pocket<br>* Other names: ATV gel;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Relative vertical clinical attachment level |  | baseline to 9 months | 
| change in RHCAL (relative horizontal clinical attachment level) |  | baseline to 9 months | 
| change in probing depth |  | baseline to 9 months | 
| change in site specific plaque index |  | baseline to 9 months | 
| change in modified sulcus bleeding index |  | baseline to 9 months |