Bone Morphogenetic Protein-2 In Grade II Furcation Defects.

Study Overview
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Brief Summary
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The present study evaluated clinically and radiographically the regenerative potential of rhBMP-2 in absorbable sponge and PRF in Grade II furcation.

Detailed Description
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44 subjects were enrolled in the study. PPD, CAL, plaque index and gingival index were recorded and the evaluation of bone fill was performed after 6 months by using ImageJ® software. After 6 months, the bone fill obtained with rhBMP-2 was higher when compared to PRF. From this trial conducted over a period of 6 months, the unique properties associated with rhBMP-2 in absorbable sponge makes it a potential agent to be used as a graft material for Grade II furcation defects.

Official Title
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Recombinant Human Bone Morphogenetic Protein-2 In Absorbable Sponge Vs Platelet Rich Fibrin (PRF) In Grade Ii Furcation Defects - A Randomized Controlled Trial

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: RhBMP-2 absorbable sponge in grade II furcation
* Procedure: PLATELET RICH FIBRIN in grade II furcation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy male and female patients of age group 20-55 yrs grade II furcation involvement and probing pocket depth of ≥5mm Exclusion Criteria: Medically compromised patients subjects who underwent radiotherapy or chemotherapy in the past 12 months patients having uncontrolled periodontal disease and subjects smoking ≥10 cigarettes per day were excluded

Ages Eligible for Study
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Minimum Age: 20 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: Group A- RhBMP-2 absorbable sponge is placed in grade II furcation and Group B- PRF is placed in the grade II furcation
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RhBMP-2<br>RhBMP-2 belongs to TGF-β super family with osteoinductive property which is capable of promoting bone formation | Drug: RhBMP-2 absorbable sponge in grade II furcation<br>* The collagen sponge is impregnated with rhBMP-2 at a concentration of 0.5 μg/ml/1cm3 and were stored at 4°C. This rhBMP-2 impregnated collagen sponge was then dispensed at grade II furcation site<br>* Other names: Experimental group;|
| Placebo Comparator: PLATELET RICH FIBRIN<br>Platelet rich fibrin(PRF) is a healing biomaterial with a great potential for bone and soft tissue regeneration, without any inflammatory reactions | Procedure: PLATELET RICH FIBRIN in grade II furcation<br>* For preparation of PRF, patient's venous blood is collected into 10ml glass tube or glass-coated plastic tube and centrifuged at 2700 rpm for 12min which leads to two different layers in the test tube, the upper platelet rich fibrin and the lower RBC portion. The formed PRF clot could then be removed from the glass tube and used in grade II furcation<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BONE FILL | The evaluation of bone fill was performed after 6 months by using ImageJ® software. | 6 MONTHS |