Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: Placebo Gel; Drug: Atorvastatin (ATV)

• Registration Number: NCT02386033
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief Summary

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

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

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-11
• Study First Submitted: 2014-11-30
• Study First Submitted QC: 2015-03-05
• Last Update Submitted: 2015-03-05
• Study First Posted: 2015-03-11
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SRP plus placebo	Placebo Gel	SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket
SRP plus Atorvastatin	Atorvastatin (ATV)	SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally

Primary Outcome Measures

Name	Time	Method
amount of bone fill	baseline to 9 months

Secondary Outcome Measures

Name	Time	Method
change in modified sulcus bleeding index	baseline to 9 months
change in Relative vertical 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 RHCAL (relative horizontal clinical attachment level)	baseline to 9 months