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This study was designed as a randomized, controlled clinical trial to evaluate the efficacy of 1% MF gel as local drug delivery in adjunct to SRP for the treatment of intrabony defects in chronic periodontitis in comparison with placebo gel.
Background: Metformin (MF) belonging to the class biguanide, is a first-line therapy for type 2 diabetes mellitus, and is one of the most commonly prescribed oral hypoglycemic drug worldwide. MF has shown to posses bone forming and bone sparring actions. The present study was designed to investigate effectiveness of MF, 1 % in an indigenously prepared biodegradable controlled-release gel as, as an adjunct to scaling and root planing (SRP) in treatment of chronic periodontitis subjects with intrabony defects.
Materials and Methods: Sixty five subjects were categorized into two treatment groups: SRP plus 1% MF and SRP plus placebo. Clinical parameters were recorded at baseline and at 3 and 6 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL). At baseline and after 6 months, radiologic assessment of intrabony defect (IBD) fill was done using computer-aided software.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator | After debridement, placebo gel was applied into the periodontal pockets with a syringe and a blunt canula. |
|
| 1% Metformin | Active Comparator | After debridement, 1% Metformin gel was applied into the periodontal pockets with a syringe and a blunt canula. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo gel | Drug | After debridement, a single dose of the placebo gel was applied into the periodontal pockets with a syringe and a blunt canula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Defect depth reduction | The primary outcome of the study is to determine the defect depth reduction by 1% metformin gel radio-graphically and compare the outcome with control group. | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Probing depth | Probing depth is measured from baseline to 3 months and 6 months in both control and test group. | Baseline to 6 months |
| Clinical attachment level | Clinical attachment level is measured from baseline to 3 months and 6 months in both control and test group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A R Pradeep, M.D.S. | Govt Dental College & Research Inst, Bangalore. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Government Dental College and Research Institute | Bangalore | Karnataka | 560002 | India |
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| 1 % Metformin gel | Drug | After debridement, 1% Metformin gel gel was applied into the periodontal pockets with a syringe and a blunt canula. |
|
| Baseline to 6 months |
| Modified sulcular bleeding index | Modified sulcular bleeding index is measured from baseline to 3 months and 6 months in both control and test group. | Baseline to 6 months |
| Plaque index | Full mouth and site specific plaque index is measured from baseline to 3 months and 6 months in both control and test group. | Baseline to 6 months |