1% Metformin in Moderate and Severe Periodontitis
Primary Purpose
Periodontitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo gel
1% Metformin gel
Sponsored by

About this trial
This is an interventional treatment trial for Periodontitis focused on measuring Metformin, Pocket depth, moderate periodontitis, severe periodontitis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo Group
1% Metformin
Arm Description
Placebo gel without the active ingredient. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 month and 6 month.
1% Metformin gel. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 month and 6 month.
Outcomes
Primary Outcome Measures
Percentage reduction in Defect depth
Secondary Outcome Measures
Plaque index
Modified sulcular bleeding index
Pocket depth
Clinical attachment level
Full Information
NCT ID
NCT02274090
First Posted
October 17, 2014
Last Updated
October 22, 2014
Sponsor
Government Dental College and Research Institute, Bangalore
1. Study Identification
Unique Protocol Identification Number
NCT02274090
Brief Title
1% Metformin in Moderate and Severe Periodontitis
Official Title
Local Drug Delivery of 1% Metformin Gel in Moderate and Severe Periodontitis Subjects: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Research Institute, Bangalore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Metformin, Pocket depth, moderate periodontitis, severe periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Placebo gel without the active ingredient. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 month and 6 month.
Arm Title
1% Metformin
Arm Type
Active Comparator
Arm Description
1% Metformin gel. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 month and 6 month.
Intervention Type
Drug
Intervention Name(s)
Placebo gel
Other Intervention Name(s)
Placebo group
Intervention Description
Placebo gel consist of drug without the active component.
Intervention Type
Drug
Intervention Name(s)
1% Metformin gel
Other Intervention Name(s)
1% Metformin group
Intervention Description
Metformin gel consist of active component.
Primary Outcome Measure Information:
Title
Percentage reduction in Defect depth
Time Frame
at 6 months and 9 months
Secondary Outcome Measure Information:
Title
Plaque index
Time Frame
at 3 , 6 and 9 months
Title
Modified sulcular bleeding index
Time Frame
at 3 , 6 and 9 months
Title
Pocket depth
Time Frame
at 3 , 6 and 9 months
Title
Clinical attachment level
Time Frame
at 3 , 6 and 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
28731373
Citation
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.
Results Reference
derived
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1% Metformin in Moderate and Severe Periodontitis
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