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Completed

NCT Number: NCT02800902

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

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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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Oral prophylaxis followed by placement of placebo gel

Other names: inactive drug

Rosuvastatin

Drug

Oral prophylaxis followed by placement of rosuvastatin gel

Other names: RSV

atorvastatin

Drug

Oral prophylaxis followed by placement of atorvastatin gel

Other names: ATV

Primary outcomes

  1. Change in Bone defect fill

    Time frame: baseline, 6 & 9 months

    Assessed in percentage

Secondary outcomes

  1. Change in modified sulcus bleeding index

    Time frame: baseline, 6 & 9 months

    scale 0-3

  2. Change in Plaque index

    Time frame: baseline, 6 & 9 months

    scale 0-3

  3. Change in pocket probing depth

    Time frame: baseline, 6 & 9 months

    measured in mm

  4. Change in relative vertical clinical attachment level

    Time frame: baseline, 6 & 9 months

    measured in mm

  5. Change in relative horizontal clinical attachment level

    Time frame: baseline, 6 & 9 months

    measured in mm

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study title

Comparative Evaluation of Locally Delivered 1.2% Atorvastatin and 1.2% Rosuvastatin Gel in Treatment of Mandibular Degree ii Furcation Defects in Chronic Periodontitis Subjects: A Randomized Controlled Clinical Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 15, 2016
Registry last updated
Jun 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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