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

Chronic Periodontitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02800902
• Other study ID #: GDCRI/ACM/PG/PhD/2/2014-2015U8
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 7, 2016
• Last updated: June 14, 2016
• Start date: May 2015
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Furcation Defects
• Periodontitis

Intervention

Drug:
• placebo
Oral prophylaxis followed by placement of placebo gel
• Rosuvastatin
Oral prophylaxis followed by placement of rosuvastatin gel
• Atorvastatin
Oral prophylaxis followed by placement of atorvastatin gel

Locations

Country	Name	City	State
India	Government Dental College and Research Institute	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bone defect fill	Assessed in percentage	baseline, 6 & 9 months	No
Secondary	Change in modified sulcus bleeding index	scale 0-3	baseline, 6 & 9 months	No
Secondary	Change in Plaque index	scale 0-3	baseline, 6 & 9 months	No
Secondary	Change in pocket probing depth	measured in mm	baseline, 6 & 9 months	No
Secondary	Change in relative vertical clinical attachment level	measured in mm	baseline, 6 & 9 months	No
Secondary	Change in relative horizontal clinical attachment level	measured in mm	baseline, 6 & 9 months	No