Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Periodontitis

Treatments: Drug: Placebo Gel; Drug: Atorvastatin (ATV)

Study type: Interventional

Funder types: Other

Identifiers

NCT02386033

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

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 30 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups, including a placebo group

SRP plus placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Gel

SRP plus Atorvastatin

Active Comparator group

Description:

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

Treatment:

Drug: Atorvastatin (ATV)