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

NCT03204058 | Completed Phase 2

• 1 other identifier: GDCRI/ACM/PG/PhD/2/2015-2016DP
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Change in Bone defect fill

  Assessed in percentage

  baseline, 6 & 12 months

Secondary Outcomes (5)

• Change in modified sulcus bleeding index

  baseline, 6 & 12 months

• Change in Plaque index

  baseline, 6 & 12 months

• Change in pocket probing depth

  baseline, 6 & 12 months

• Change in clinical attachment level

  baseline, 6 & 12 months

• change in intrabony defect depth

  baseline, 6 & 12 months

Study Arms (3)

group 1

PLACEBO COMPARATOR

Scaling and root planing (SRP) followed by placebo gel local drug delivery

Drug: Placebos

group 2

ACTIVE COMPARATOR

SRP followed by 1.2% rosuvastatin (RSV) gel

Drug: Rosuvastatin

group 3

ACTIVE COMPARATOR

SRP followed by 1% Metformin ( MF) gel

Drug: Metformin

Interventions

Placebos DRUG

Oral prophylaxis followed by placement of placebo gel

Also known as: Inactive drug

group 1

Rosuvastatin DRUG

Oral prophylaxis followed by placement of rosuvastatin gel

Also known as: RSV

group 2

Metformin DRUG

Oral prophylaxis followed by placement of metformin gel

Also known as: MF

group 3

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Rosuvastatin Calcium; Metformin

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and HOD, Dept of Periodontology

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: June 29, 2017
• Study Start: February 10, 2016
• Primary Completion: February 23, 2017
• Study Completion: February 23, 2017
• Last Updated: June 29, 2017

Record last verified: 2017-06