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

G

Government Dental College and Research Institute, Bangalore

Status and phase

Completed
Phase 3
Phase 2

Conditions

Chronic Periodontitis

Treatments

Drug: Placebos
Drug: Rosuvastatin
Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT03204058
GDCRI/ACM/PG/PhD/2/2015-2016DP

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

30 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 3 patient groups, including a placebo group

group 1
Placebo Comparator group
Description:
Scaling and root planing (SRP) followed by placebo gel local drug delivery
Treatment:
Drug: Placebos
group 2
Active Comparator group
Description:
SRP followed by 1.2% rosuvastatin (RSV) gel
Treatment:
Drug: Rosuvastatin
group 3
Active Comparator group
Description:
SRP followed by 1% Metformin ( MF) gel
Treatment:
Drug: Metformin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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