1.2% Atorvastatin and 1.2% Simvastatin in Treatment of Chronic Periodontitis

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Periodontitis

Treatments: Drug: 1.2% Atorvastatin local drug delivery; Drug: 1.2% simvastatin local drug delivery; Drug: Placebo local drug delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT02060032

GDCRI/ACM/PG/PhD/2011-2012/B

Details and patient eligibility

About

Background: Statins are the recently evolved agents that aid in periodontal regeneration and ultimately attaining periodontal health. Atorvastatin (ATV) and Simvastatin (SMV) are specific competitive inhibitors of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. The present study was designed to evaluate and compare the effectiveness of 1.2% ATV, and 1.2% SMV as an adjunct to scaling and root planing (SRP) in the treatment subjects with chronic periodontitis.

Methods: Ninety six subjects were categorized into three treatment groups: SRP plus 1.2% ATV, SRP plus 1.2% SMV and SRP plus placebo. Clinical parameters; full mouth plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and relative attachment level (RAL) were recorded at baseline before SRP and at 3, 6 and 9 months. Percentage radiographic defect depth reduction was evaluated using computer-aided software at baseline, 6 months and 9 months.

Enrollment: 96 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe CP subjects with PD ≥ 5 mm or clinical attachment level (CAL) ≥ 4 mm and vertical bone loss ≥3 mm on intraoral periapical radiographs and no history of antibiotic or periodontal therapy in the preceding 6 months

Exclusion criteria

• Individuals with systemic diseases known to alter the course of periodontal disease and treatment outcome, known or suspected allergy to the SMV/ATV/statin group, those on systemic SMV/ATV/statin therapy, individuals with aggressive periodontitis, use of tobacco in any form, alcoholics, individuals with diabetes, immunocompromised individuals, and pregnant or lactating females

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 3 patient groups, including a placebo group

Atorvastatin

Active Comparator group

Description:

1.2% atorvastatin local drug delivery

Treatment:

Drug: 1.2% Atorvastatin local drug delivery

Simvastatin

Sham Comparator group

Description:

1.2% simvastatin local drug delivery

Treatment:

Drug: 1.2% simvastatin local drug delivery

Placebo

Placebo Comparator group

Description:

Placebo local drug delivery

Treatment:

Drug: Placebo local drug delivery