1% Metformin in Moderate and Severe Periodontitis

Local Drug Delivery of 1% Metformin Gel in Moderate and Severe Periodontitis Subjects: a Randomized Controlled Clinical Trial

This study evaluates the efficacy of 1% Metformin gel in treatment of moderate and severe periodontitis subject.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Drug: Placebo gel; Drug: 1% Metformin gel

Detailed Description

Metformin (MF) has stimulating effect of osteoblastic lineages. In the present study seventy subjects were categorized into two treatment groups: Scaling and root planing (SRP) plus 1% MF and SRP plus placebo. Clinical parameters were recorded at baseline, 3, 6 and 9 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL). Radiologic assessment of intra bony defect (IBD) and percentage defect depth reduction (DDR%) was done at baseline, 6 months and 9 months interval using computer-aided software. PD, CAL and defect depth reduction was evaluated in initial pocket depth of ≥5mm and ≥7mm subgroup within placebo and MF group.

Mean probing depth reduction and mean clinical attachment level gain was found to greater in MF group than placebo group at all visits. Significantly greater mean percentage of defect depth reduction was found in MF group than the placebo sites in both ≥5mm and ≥7mm of initial periodontal pocket depth. In MF group improvement in clinical parameter were similar in both the sites, with slightly better improvement in clinical parameters in initial pocket depth ≥7mm with respect to CAL, IBD and DDR% while PD was significantly reduced in initial pocket depth of ≥7mm.

There was greater decrease in mSBI and PD and more CAL gain with significant IBD depth reduction at the sites treated with SRP plus locally delivered MF in chronic periodontitis subjects with intrabony defects as compared to placebo and effect of MF was similar in initial moderate periodontal pockets and deep pocket depths.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Systemically healthy subjects, Pocket depth ≥ 5 mm, Clinical attachment level ≥ 4 mm and vertical bone loss ≥ 3 mm on intraoral periapical radiographs, with no history of periodontal therapy in the last 6 months.

Exclusion Criteria:

• subjects allergic to MF, those on systemic MF therapy, subjects with aggressive periodontitis, immunocompromised subjects, use of tobacco in any form, alcoholics, lactating and pregnant females.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group; Placebo gel without the active ingredient. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 month and 6 month.	Drug: Placebo gel; Placebo gel consist of drug without the active component.; Other Names: Placebo group
Active Comparator: 1% Metformin; 1% Metformin gel. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 month and 6 month.	Drug: 1% Metformin gel; Metformin gel consist of active component.; Other Names: 1% Metformin group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage reduction in Defect depth	at 6 months and 9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Plaque index	at 3 , 6 and 9 months
Modified sulcular bleeding index	at 3 , 6 and 9 months
Pocket depth	at 3 , 6 and 9 months
Clinical attachment level	at 3 , 6 and 9 months

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore

Publications and helpful links

General Publications

• Pradeep AR, Patnaik K, Nagpal K, Karvekar S, Guruprasad CN, Kumaraswamy KM. Efficacy of 1% Metformin Gel in Patients With Moderate and Severe Chronic Periodontitis: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Oct;88(10):1023-1029. doi: 10.1902/jop.2017.150096. Epub 2017 Jul 21.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: October 17, 2014
• First Submitted That Met QC Criteria: October 22, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Estimate): October 24, 2014
• Last Update Submitted That Met QC Criteria: October 22, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Metformin; severe periodontitis; Pocket depth; moderate periodontitis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: GDCRI/ACM/PG/PhD/10B/2013-14