RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT04368650|
Recruitment Status : Completed
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Periodontitis||Drug: BMP-2 Procedure: PRF||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of Rhbmp-2 And Sticky Bone in Intrabony Defects - A Randomized Controlled Trial|
|Actual Study Start Date :||December 5, 2017|
|Actual Primary Completion Date :||September 20, 2019|
|Actual Study Completion Date :||October 11, 2019|
Experimental: Main treatment group
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.
lyophilized Human Bone Morphogenetic Protein-2 was used as an active drug.
Other Name: Experimental group
Active Comparator: Control
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.
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
Other Name: Sticky bone group
- bone fill [ Time Frame: 6 months ]bone fill evaluation done after 6 months by using ImageJ® software
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368650
|SVS Institute of Dental Sciences, Mahabubnagar|
|Hyderabad, Andhra Pradesh, India, 509002|