Locally Delivered Atorvastatin & Rosuvastatin for Treatment of Furcation Defects in Chronic Periodontitis

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: placebo; Drug: Atorvastatin; Drug: Rosuvastatin

• Registration Number: NCT02800902
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief Summary

Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.

Detailed Description

Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.

Methods: Ninety patients with mandibular buccal class II furcation defects were randomly allocated into three treatment groups: SRP plus placebo gel (group 1), SRP plus 1.2% RSV gel (group 2) and 1.2% ATV gel (group3). Clinical and radiographic parameters were recorded at baseline then after 6 months. The gels were redelivered at the respective sites at this 6 month appointment. Then again all clinical and radiographic parameters were recorded after 3 months. (9 months from baseline)

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-06
• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-06-14
• Last Update Submitted: 2016-06-14
• Study First Posted: 2016-06-15
• Last Update Posted: 2016-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Systemically healthy patients with mandibular class II furcation defects and asymptomatic endodontically vital mandibular molars with radiolucency in furcation area with PD ≥ 5mm and horizontal PD ≥ 3mm and with no history of antibiotic or any periodontal therapy in past 6 months were included in the study

Exclusion Criteria

• Subjects with any known systemic disease, allergic to statins, on systemic statin therapy, alcoholics, tobacco users, pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	placebo	Scaling and root planing (SRP) followed by placebo gel local drug delivery
group 3	Atorvastatin	SRP followed by 1.2% Atorvastatin (ATV) gel
group 2	Rosuvastatin	SRP followed by 1.2% rosuvastatin (RSV) gel

Primary Outcome Measures

Name	Time	Method
Change in Bone defect fill	baseline, 6 & 9 months	Assessed in percentage

Secondary Outcome Measures

Name	Time	Method
Change in relative vertical clinical attachment level	baseline, 6 & 9 months	measured in mm
Change in modified sulcus bleeding index	baseline, 6 & 9 months	scale 0-3
Change in Plaque index	baseline, 6 & 9 months	scale 0-3
Change in pocket probing depth	baseline, 6 & 9 months	measured in mm
Change in relative horizontal clinical attachment level	baseline, 6 & 9 months	measured in mm

Trial Locations

Locations (1)

Government Dental College and Research Institute; 🇮🇳 Bangalore, Karnataka, India