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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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group 1

Scaling and root planing (SRP) followed by placebo gel local drug delivery

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Oral prophylaxis followed by placement of placebo gel

group 2

SRP followed by 1.2% rosuvastatin (RSV) gel

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

Oral prophylaxis followed by placement of rosuvastatin gel

group 3

SRP followed by 1.2% Atorvastatin (ATV) gel

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Oral prophylaxis followed by placement of atorvastatin gel

Interventions

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placebo

Oral prophylaxis followed by placement of placebo gel

Intervention Type DRUG

Rosuvastatin

Oral prophylaxis followed by placement of rosuvastatin gel

Intervention Type DRUG

Atorvastatin

Oral prophylaxis followed by placement of atorvastatin gel

Intervention Type DRUG

Other Intervention Names

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inactive drug RSV ATV

Eligibility Criteria

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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