Locally Delivered Metformin & Rosuvastatin for Treatment of Intrabony Defects in Chronic Periodontitis
- Conditions
- Chronic Periodontitis
- Interventions
- Registration Number
- NCT03204058
- Lead Sponsor
- Government Dental College and Research Institute, Bangalore
- Brief Summary
Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favourable effect on alveolar bone. 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) have shown to have bone stimulatory and anti-inflammatory effects.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 1MF gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of intrabony defects.
- Detailed Description
Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favourable effect on alveolar bone. 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) have shown to have bone stimulatory and anti-inflammatory effects.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 1MF gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of intrabony defects.
Methods: Ninety patients with intrabony defects were randomly allocated into three treatment groups: SRP plus placebo gel (group 1), SRP plus 1.2% RSV gel (group 2) and 1% MF gel (group3). Clinical and radiographic parameters were recorded at baseline then after 6 months. The gels were delivered at the respective sites at baseline . Then again all clinical and radiographic parameters were recorded after 6 months and 12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- All the subjects were systemically healthy subjects with sites having CAL ≥ 3 mm, PPD ≥ 5 mm, vertical bone loss ≥ 3 mm on intraoral periapical radiographs (IOPA) and subjects with no history of periodontal intervention in the last 6 months.
patients with systemic diseases like cardiovascular disease diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.
pregnant/lactating females tobacco users alcoholics patients with unsatisfactory oral hygiene (plaque index greater than 1.5) teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility Furthermore, patients allergic to Metformin and rosuvastatin or those taking Metformin and rosuvastatin systemically were excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group 1 Placebos Scaling and root planing (SRP) followed by placebo gel local drug delivery group 2 Rosuvastatin SRP followed by 1.2% rosuvastatin (RSV) gel group 3 Metformin SRP followed by 1% Metformin ( MF) gel
- Primary Outcome Measures
Name Time Method Change in Bone defect fill baseline, 6 & 12 months Assessed in percentage
- Secondary Outcome Measures
Name Time Method Change in pocket probing depth baseline, 6 & 12 months measured in mm
Change in clinical attachment level baseline, 6 & 12 months measured in mm
Change in modified sulcus bleeding index baseline, 6 & 12 months scale 0-3
Change in Plaque index baseline, 6 & 12 months scale 0-3
change in intrabony defect depth baseline, 6 & 12 months measured in mm ( Radiograph)