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The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of autologous PRF, 1% alendronate (ALN) and 1.2% atorvastatin (ATV) gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis.
Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Alendronate and Atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of autologous PRF, 1% alendronate and 1.2% atorvastatin gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis.
Methods: 120 CP subjects with IBD ≥3 mm deep and probing depth (PD) ≥5 mm, following scaling and root planing (SRP), were categorized into four treatment groups: 1) OFD 2) OFD with PRF 3) OFD with 1% ALN gel and 4) OFD with 1.2% ATV gel. Clinical parameters including site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD) and relative attachment level (RAL) as well as percentage radiographic intrabony defect depth reduction (DDR) were recorded at baseline before surgery and 9 months post-operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open flap debridement group | Active Comparator | SRP with Open flap debridement (OFD) alone for treating intrabony defect |
|
| PRF group | Active Comparator | SRP with Open flap debridement (OFD) with autologous Platelet rich fibrin (PRF) placement into intrabony defect |
|
| Alendronate group | Active Comparator | SRP with Open flap debridement (OFD) with 1% Alendronate (ALN) placement into intrabony defect |
|
| Atorvastatin group | Active Comparator | SRP with Open flap debridement (OFD) with 1.2% Atorvastatin (ATV) placement into intrabony defect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open flap debridement (OFD) | Procedure | Oral prophylaxis followed by Open flap debridement (OFD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| defect depth reduction (DDR) | Change from baseline to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in clinical attachment level (CAL) | Change from baseline to 9 months | |
| change in probing pocket depths (PPD) | Change from baseline to 9 months | |
| change in plaque index (PI) |
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Inclusion Criteria:
Exclusion Criteria:
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| OFD with PRF | Biological | Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect |
|
| OFD with ALN | Drug | Oral prophylaxis followed by Open flap debridement (OFD) with 1% ALN gel placement into the bone defect |
|
| OFD with ATV | Drug | Oral prophylaxis followed by Open flap debridement (OFD) with 1.2% ATV gel placement into the bone defect |
|
| Change from baseline to 9 months |
| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D056690 | Prolactin-Releasing Hormone |
| ID | Term |
|---|---|
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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