1% Metformin in Moderate and Severe Periodontitis

NCT ID: NCT02274090

Last Updated: 2014-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-08-31

Brief Summary

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

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.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo Group

Placebo gel without the active ingredient. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 month and 6 month.

Group Type: PLACEBO_COMPARATOR

Placebo gel

Intervention Type: DRUG

Placebo gel consist of drug without the active component.

1% Metformin

1% Metformin gel. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 month and 6 month.

Group Type: ACTIVE_COMPARATOR

1% Metformin gel

Intervention Type: DRUG

Metformin gel consist of active component.

Interventions

Placebo gel

Placebo gel consist of drug without the active component.

Intervention Type: DRUG

1% Metformin gel

Metformin gel consist of active component.

Intervention Type: DRUG

Other Intervention Names

Placebo group; 1% Metformin group

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Government Dental College and Research Institute, Bangalore

OTHER

Sponsor Role: lead

Responsible Party

Dr. A R Pradeep

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 28731373 (View on PubMed)

Other Identifiers

GDCRI/ACM/PG/PhD/10B/2013-14

Identifier Type: -

Identifier Source: org_study_id