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

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: 1.2% Atorvastatin local drug delivery; Drug: 1.2% simvastatin local drug delivery; Drug: Placebo local drug delivery

• Registration Number: NCT02060032
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-02
• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-09
• Last Update Submitted: 2014-02-09
• Study First Posted: 2014-02-11
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin	1.2% Atorvastatin local drug delivery	1.2% atorvastatin local drug delivery
Simvastatin	1.2% simvastatin local drug delivery	1.2% simvastatin local drug delivery
Placebo	Placebo local drug delivery	Placebo local drug delivery

Primary Outcome Measures

Name	Time	Method
Change in Radiographic intra-bony defect depth.	9 months from baseline	The primary outcome of the study was change in radiographic intra-bony defect depth from baseline to 9 months in all the groups. Intra-bony defect depth was measured on the radiograph by measuring the vertical distance from the crest of the alveolar bone to the base of the defect.

Secondary Outcome Measures

Name	Time	Method
Change in Probing depth.	9 months from baseline	Probing depth was measured from gingival margin to the base of pocket with a University of North Carolina no. 15 color-coded periodontal probe. change in probing depth was measured from baseline to 9 months.
Change in Relative attachment level	9 months from baseline	Relative attachment level was measured from a fixed point on the acrylic stent to the to the base of pocket. . A custom-made acrylic stent and a University of North Carolina no. 15 color-coded periodontal probe were used to standardize the measurement. Change was measured from baseline to 9 months.
Change in mSBI (gingival index)	9 months from baseline	modified sulcus bleeding index was measured at baseline and 9 months and the change in the values was taken as secondary outcome measure.
Change in plaque index	9 months from baseline	Sillness and loe plaque index was measured at baseline an 9 months and change in the values was taken as secondary outcome variable.