Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: Placebo Gel; Drug: Atorvastatin (ATV)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: SRP plus placebo; SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket	Drug: Placebo Gel; After SRP, placebo gel was delivered subgingivally into the pocket
Active Comparator: SRP plus Atorvastatin; SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally	Drug: Atorvastatin (ATV); After SRP, ATV gel was delivered subgingivally into the pocket; Other Names: ATV gel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: November 30, 2014
• First Submitted That Met QC Criteria: March 5, 2015
• First Posted (Estimate): March 11, 2015

Study Record Updates

• Last Update Posted (Estimate): March 11, 2015
• Last Update Submitted That Met QC Criteria: March 5, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Furcation Defects; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2013-2014AB