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Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favourable effect on alveolar bone. The present study aims to explore the efficacy of 1% MF gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of Class II furcation defects in comparison with placebo gel.
Background: Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favourable effect on alveolar bone. The present study aims to explore the efficacy of 1% MF gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of Class II furcation defects in comparison with placebo gel.
Methods: Sixty four patients with single mandibular buccal class II furcation defects were categorized into two treatment groups: SRP plus 1% MF (group 1) and SRP plus placebo (group 2). Clinical parameters were recorded at baseline, 3 months, 6 months, and 9 months, and radiographic parameters were recorded at baseline, 6 months, and 9 months. Defect fill at baseline, 6 months, and 9 months was calculated on standardized radiographs using image analysis software.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRP and placebo | Placebo Comparator | Oral prophylaxis followed by placement of placebo gel |
|
| SRP and 1% metformin | Active Comparator | Oral prophylaxis followed by placement of 1% metformin gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRP and placebo | Drug | Placement of placebo gel into classII furcation defects after scaling and root planing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone defect fill | Assesed in percentage | baseline to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| modified sulcus bleeding index | scale 0-3 | baseline to 9 months |
| plaque index | scale 0-3 | baseline to 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A R Pradeep, MDS | GDCRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Government Dental College and Research Institute | Bangalore | Karnataka | 560002 | India |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| SRP and 1% metformin | Drug | Placement of 1% metformin gel into classII furcation defects after scaling and root planing |
|
|
| pocket probing depth | measured in mm | baseline to 9 months |
| relative vertical clinical attachment level | measured in mm | baseline to 9 months |
| relative horizontal clinical attachment level | measured in mm | baseline to 9 months |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |