Clinical Trial: Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Efficacy of Subgingivally Delivered Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial .
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 Summary: Two groups were made. One was delivered with ATV after SRP, the other was delivered with placebo gel after SRP.
Sponsor: Government Dental College and Research Institute, Bangalore
Current Primary Outcome: amount of bone fill [ Time Frame: baseline to 9 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- change in Relative vertical clinical attachment level [ Time Frame: baseline to 9 months ]
- change in RHCAL (relative horizontal clinical attachment level) [ Time Frame: baseline to 9 months ]
- change in probing depth [ Time Frame: baseline to 9 months ]
- change in site specific plaque index [ Time Frame: baseline to 9 months ]
- change in modified sulcus bleeding index [ Time Frame: baseline to 9 months ]
Original Secondary Outcome: Same as current
Information By: Government Dental College and Research Institute, Bangalore
Dates:
Date Received: November 30, 2014
Date Started: November 2013
Date Completion:
Last Updated: March 5, 2015
Last Verified: November 2014