Regenerative Potential of Advanced Platelet Rich Fibrin and Bioactive Glass (Perioglas®).

Study Overview
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Brief Summary
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The aim of this study is to evaluate and compare the regenerative potential of Advanced Platelet Rich Fibrin (A-PRF) and Bioactive Glass (Perioglas®) bone graft in the treatment of intrabony defects in chronic periodontitis patients.

Detailed Description
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45 sites with vertical intrabony alveolar defects will be selected. These defect sites will be allocated randomly into 3 groups as Group I, Group II and Group III. Group I will be treated with open flap debridement and filled with A-PRF Group II will be treated with open flap debridement and filled with Bioactive glass (Perioglas®) Group III will be treated with open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF.

Official Title
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Regenerative Potential of Advanced Platelet Rich Fibrin (A-PRF) and Bioactive Glass (Perioglas®) Bone Graft in the Treatment of Intrabony Defects; A Comparative Clinico Radiographic Study.

Conditions
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Chronic Periodontitis, Bone Loss, Intrabony Periodontal Defect

Intervention / Treatment
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* Procedure: open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin)
* Procedure: open flap debridement and filled with Bioactive glass (Perioglas®)
* Drug: open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 25 to 55 years. Gender: Both males and females will be included in the study. Co-operative and motivated patients committed to oral hygiene. Patients exhibiting intrabony defects. Exclusion Criteria: Patients with contraindication to periodontal surgery & local anesthesia. Any systemic disease affecting the bone density and outcome of periodontal therapy. Smokers, alcoholics, and patients with other adverse habits. Pregnant, nursing and menopausal women. Any known allergy/ hypersensitivity to any product used in this study. Patients on long-term systemic therapy (antibiotics, anti-inflammatory bisphosphonates, hormonal replacement therapy and any other), taking any drug known to have periodontal implications that may interfere with wound healing. Patients taking any anti-platelet and anticoagulant medication. Patients who have undergone periodontal treatment within a period of past 1 year.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 45 sites with vertical intrabony alveolar defects will be selected. These defect sites will be allocated randomly into 3 groups as Group I, Group II and Group III. Group I will be treated with open flap debridement and filled with A-PRF Group II will be treated with open flap debridement and filled with Bioactive glass (Perioglas®) Group III will be treated with open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: open flap debridement and filled with A-PRF<br>After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure. | Procedure: open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin)<br>* After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.<br>|
| Active Comparator: open flap debridement and filled with Bioactive glass (Perioglas®)<br>After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of Bioactive glass (Perioglas®) in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure. | Procedure: open flap debridement and filled with Bioactive glass (Perioglas®)<br>* After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of perioglas in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.<br>* Other names: perioglas;|
| Active Comparator: with open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF.<br>After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of Bioactive glass (Perioglas®) along with A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure. | Drug: open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF<br>* After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of perioglas with A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.<br>* Other names: perioglas;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probing depth | change in probing pocket depth | baseline, 3 months, 6 months | 
| relative attachment level | change in attachment level | baseline, 3 months, 6 months | 
| radiographic linear bone change | radiographic linear bone change through radiographic grid | change from baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque index site specific | Plaque index -Silness and Loe | baseline, 3 months, 6 months | 
| Gingival index site specific | Gingival index- Loe and Silness | baseline, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intrabony periodontal defect, regeneration, platelet rich fibrin, bioactive glass