Locally Delivered Metformin & Rosuvastatin for Treatment of Intrabony Defects in Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Placebos; Rosuvastatin; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral prophylaxis followed by placement of placebo gel; Oral prophylaxis followed by placement of rosuvastatin gel; Oral prophylaxis followed by placement of metformin gel
Other intervention name(s): Inactive drug; RSV; MF
Intervention MeSH terms: Metformin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment