A Phase 2/3 interventional study of Placebos and Rosuvastatin in Chronic Periodontitis, sponsored by Government Dental College and Research Institute, Bangalore. Completed. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-29.
Sponsored by Government Dental College and Research Institute, Bangalore · Phase 2/3, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
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Scaling and root planing (SRP) followed by placebo gel local drug delivery
Drug: Placebos
SRP followed by 1.2% rosuvastatin (RSV) gel
Drug: Rosuvastatin
SRP followed by 1% Metformin ( MF) gel
Drug: Metformin
Oral prophylaxis followed by placement of placebo gel
Also known as: Inactive drug
Oral prophylaxis followed by placement of rosuvastatin gel
Also known as: RSV
Oral prophylaxis followed by placement of metformin gel
Also known as: MF
Change in Bone defect fill
Assessed in percentage
Time frame: baseline, 6 & 12 months
Change in modified sulcus bleeding index
scale 0-3
Time frame: baseline, 6 & 12 months
Change in Plaque index
scale 0-3
Time frame: baseline, 6 & 12 months
Change in pocket probing depth
measured in mm
Time frame: baseline, 6 & 12 months
Change in clinical attachment level
measured in mm
Time frame: baseline, 6 & 12 months
change in intrabony defect depth
measured in mm ( Radiograph)
Time frame: baseline, 6 & 12 months
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Government Dental College and Research Institute, Bangalore