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ABSTRACT:
Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Metformin (MF), a member of biguanide group has been shown to facilitate osteoblast differentiation and thus may exhibit a favourable effect on alveolar bone . Current study was designed to evaluate the combined efficacy of PRF and 1% MF gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis (CP) subjects.
Methods: One hundred and twenty subjects with single defects were categorized into four treatment groups: OFD alone, OFD with PRF, OFD with 1% MF and OFD + PRF+1% MF. Clinical parameters like site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and gingival marginal level (GML) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic intra-bony defect depth reduction was evaluated using computer-aided software at baseline and 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM1- open flap debridement (OFD) | Placebo Comparator | open flap debridement done for 30 subjects. After debridement, Metformin or PRF was not added into the intrabony defect. |
|
| ARM2- open flap debridement plus PRF(Platelet rich fibrin) | Experimental | After open flap debridement, PRF( Platelet rich fibrin) was added into the intrabony defect. No. of subjects= 30 |
|
| ARM3- open flap debridement plus 1%Metformin | Experimental | After open flap debridement, 1% metformin was added into the intrabony defect No. of subjects= 30 |
|
| ARM4- open flap debridement plus PRF plus metformin | Experimental | After open flap debridement, PRF and 1% metformin was added into the intrabony defect. No. of subject- 30 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open flap debridement (OFD) | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| radiographic defect depth reduction from baseline to 9 months. | The primary outcome of the study was radiographic defect depth reduction from baseline to 9 months | radiographic defect depth reduction from baseline to 9 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PD | PD at 3,6 and 9 months was evaluated by using a UNC-15 probe from the gingival margin to the base of pockrt | Assessment of PD at 3,6 and 9 months |
| Change in RAL | RAL is measured by measuring the distance between apical level of customized acrylic stent to pocket base |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| 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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| Platelet rich fibrin (PRF) | Other |
|
| Metformin | Drug |
|
| Assessment of RAL at 3,6 and 9 months |
| Change in GML | Assessment of GML is done from apical level of customized acrylic stent, using a UNC 15 periodontal probe | Assessment of GML at 3,6 and 9 months |
| Change in mSBI | mSBI is assessed by noting the amount of bleeding after probing, at 3,6 and 9 months | Assessment of mSBI at 3,6 and 9 months |
| Cgange in PI | PI is assessed by noting the amount of plaque and the site of plaque present on the tooth surface at 3,6 and 9 months | Assessment of PI at 3,6 and 9 months |