Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386033
• Other study ID #: GDCRI/ACM/PG/PhD/2/2013-2014AB
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 30, 2014
• Last updated: March 5, 2015
• Start date: November 2013
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Furcation Defects
• Periodontitis

Intervention

Drug:
• Atorvastatin (ATV)
After SRP, ATV gel was delivered subgingivally into the pocket
• Placebo Gel
After SRP, placebo gel was delivered subgingivally into the pocket

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of bone fill		baseline to 9 months	No
Secondary	change in Relative vertical clinical attachment level		baseline to 9 months	No
Secondary	change in RHCAL (relative horizontal clinical attachment level)		baseline to 9 months	No
Secondary	change in probing depth		baseline to 9 months	No
Secondary	change in site specific plaque index		baseline to 9 months	No
Secondary	change in modified sulcus bleeding index		baseline to 9 months	No