Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects

NCT ID: NCT02386033

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-07-31

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.

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SRP plus placebo

SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket

Group Type: PLACEBO_COMPARATOR

Placebo Gel

Intervention Type: DRUG

After SRP, placebo gel was delivered subgingivally into the pocket

SRP plus Atorvastatin

SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally

Group Type: ACTIVE_COMPARATOR

Atorvastatin (ATV)

Intervention Type: DRUG

After SRP, ATV gel was delivered subgingivally into the pocket

Interventions

Atorvastatin (ATV)

After SRP, ATV gel was delivered subgingivally into the pocket

Intervention Type: DRUG

Placebo Gel

After SRP, placebo gel was delivered subgingivally into the pocket

Intervention Type: DRUG

Other Intervention Names

ATV gel

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Government Dental College and Research Institute, Bangalore

OTHER

Sponsor Role: lead

Responsible Party

Dr. A R Pradeep

Professor and head, department of periodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

GDCRI/ACM/PG/PhD/2/2013-2014AB

Identifier Type: -

Identifier Source: org_study_id