Comparative Evaluation Of 1.2% Atorvastatin and 1.2% Simvastatin Gel Local Drug Delivery And Redelivery In Chronic Periodontitis Subjects With Diabetes Mellitus: A Randomized Controlled Clinical Trial.
- Conditions
- Chronic Periodontitis Wth Diabetes Mellitus
- Interventions
- Registration Number
- NCT03745300
- Lead Sponsor
- Government Dental College and Research Institute, Bangalore
- Brief Summary
Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2% Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM).
- Detailed Description
Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2% Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM). 120 subjects with intrabony defects were divided into three groups;group 1- SRP plus 1.2% ATV ; group 2- SRP PLUS 1.2% SMV; and group 3- SRP plus placebo gel. Clinical and radiographic measurements were taken at baseline, at 6 months and respective gels were redelivered subgingivally in respective groups . Measurements were repeated again at 3 months i.e. 9 months from baseline.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- well controlled type 2 diabetes mellitus patients classified based on criteria given by American diabetes association with CP with PD≥5mm and CAL ≥3mm and presence of IBD ≥ 3 mm (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPAR] after phase I therapy
- 1)patients with known allergy to statins; 2) Patients with systemic conditions / medications known to affect the periodontal status; 3) aggressive and refractory periodontitis 4) Hematological disorders 5) pregnancy/lactation; and 6) Smoking and tobacco use in any form 7) Immunocompromised individuals.8). patients with poor plaque control. 9). non vital teeth, carious teeth warranting restorations, third molars and mobility of at least grade II were excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GROUP 3 PLACEBO Scaling and root planing (SRP) followed by placebo gel local drug delivery GROUP 2 SIMVASTATIN Scaling and root planing (SRP) followed by 1.2% simvastatin gel local drug delivery GROUP 1 ATORVASTATIN Scaling and root planing (SRP) followed by 1.2% atorvastatin gel local drug delivery
- Primary Outcome Measures
Name Time Method change in defect depth 6 and 9 months assessed in percentage
- Secondary Outcome Measures
Name Time Method change in probing depth (PD) baseline, 6 and 9 months change in Clinical Attachment Level (CAL) baseline, 6 and 9 months CHANGE IN Plaque Index (PI) baseline, 6 and 9 months change in modified Sulcus Bleding Index (mSBI) baseline, 6 and 9 months
Trial Locations
- Locations (1)
Department of Periodontics, GDCRI Bangalore
🇮🇳Bangalore, Karnataka, India