NCT02274090

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

9 months

First QC Date

October 17, 2014

Last Update Submit

October 22, 2014

Conditions

Periodontitis

Keywords

MetforminPocket depthmoderate periodontitissevere periodontitis

Outcome Measures

Primary Outcomes (1)

  • Percentage reduction in Defect depth

    at 6 months and 9 months

Secondary Outcomes (4)

  • 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

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebo gel

1% Metformin

ACTIVE COMPARATOR

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

Drug: 1% Metformin gel

Interventions

Placebo gelDRUG

Placebo gel consist of drug without the active component.

Also known as: Placebo group
Placebo Group
1% Metformin gelDRUG

Metformin gel consist of active component.

Also known as: 1% Metformin group
1% Metformin

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28731373DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

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

Study Record Dates

First Submitted

October 17, 2014

First Posted

October 24, 2014

Study Start

November 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

October 24, 2014

Record last verified: 2014-10