Locally Delivered Metformin & Rosuvastatin for Treatment of Intrabony Defects in Chronic Periodontitis

Comparative Evaluation of Locally Delivered 1% Metformin and 1.2% Rosuvastatin Gel in Treatment of Intrabony Defects in Chronic Periodontitis Subjects: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: Metformin; Drug: Placebos; Drug: Rosuvastatin

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- 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.

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: group 1; Scaling and root planing (SRP) followed by placebo gel local drug delivery	Drug: Placebos; Oral prophylaxis followed by placement of placebo gel; Other Names: Inactive drug
ACTIVE_COMPARATOR: group 2; SRP followed by 1.2% rosuvastatin (RSV) gel	Drug: Rosuvastatin; Oral prophylaxis followed by placement of rosuvastatin gel; Other Names: RSV
ACTIVE_COMPARATOR: group 3; SRP followed by 1% Metformin ( MF) gel	Drug: Metformin; Oral prophylaxis followed by placement of metformin gel; Other Names: MF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bone defect fill	Assessed in percentage	baseline, 6 & 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in modified sulcus bleeding index	scale 0-3	baseline, 6 & 12 months
Change in Plaque index	scale 0-3	baseline, 6 & 12 months
Change in pocket probing depth	measured in mm	baseline, 6 & 12 months
Change in clinical attachment level	measured in mm	baseline, 6 & 12 months
change in intrabony defect depth	measured in mm ( Radiograph)	baseline, 6 & 12 months

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2016
• Primary Completion (ACTUAL): February 23, 2017
• Study Completion (ACTUAL): February 23, 2017

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (ACTUAL): June 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; Metformin
• Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2015-2016DP