RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial

Study Overview
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Brief Summary
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This study evaluated the regenerative potential of rhBMP-2 gel in intrabony defects when compared to sticky bone (control).

Detailed Description
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It was done in 40 subjects who were evaluated for a period of 6 months. the results were evaluated clinically (CAL, PPD) and radiographically (bone fill) and after 6 months.

Official Title
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Evaluation of Rhbmp-2 And Sticky Bone in Intrabony Defects - A Randomized Controlled Trial

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: BMP-2
* Procedure: PRF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy male and female patients age 20-55 years with intrabony defects and probing pocket depth of ≥5mm after initial therapy were included in the study. Exclusion Criteria: Medically compromised patients, Subjects who underwent radiotherapy or chemotherapy and smokers 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: Randomization involved the computerized generation of the allocation sequence in random permuted blocks (block randomization) and blinding was ensured by assigning the block of sites to study groups according to the specified sequence by a second operator who coded the two treatment sites selected from every patient by the first operator into the following groups
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main treatment group<br>The in situ BMP-2 gel was prepared to a concentration of approximately 0.5 μg/ml and were stored at 4oC. The gel was then dispensed at site of interest in the study. | Drug: BMP-2<br>* lyophilized Human Bone Morphogenetic Protein-2 was used as an active drug.<br>* Other names: Experimental group;|
| Active Comparator: Control<br>In patients selected for control group, after degranulation, sticky bone was used to fill the defect. The surgical site was protected and covered using a periodontal dressing. | Procedure: PRF<br>* For the preparation of sticky bone, the patient's venous blood is collected and centrifuged at 2400rpm for 2min which leads to two different layers in the vacutainer the upper autologous fibrin glue (AFG) and the lower RBC portion, the upper AFG is mixed with a particulate bone graft (hydroxyapatite). Within 5-10 min fibrin meshwork was formed<br>* Other names: Sticky bone group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone fill | bone fill evaluation done after 6 months by using ImageJ® software | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sticky bone, Intrabony defects, Regeneration