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RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04368650
Recruitment Status : Completed
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Information provided by (Responsible Party):
Dr R Viswa Chandra, SVS Institute of Dental Sciences

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

Condition or disease Intervention/treatment Phase
Periodontitis Drug: BMP-2 Procedure: PRF Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.
Drug: BMP-2
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.
Procedure: PRF
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

Primary Outcome Measures :
  1. bone fill [ Time Frame: 6 months ]
    bone fill evaluation done after 6 months by using ImageJ® software

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04368650

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SVS Institute of Dental Sciences, Mahabubnagar
Hyderabad, Andhra Pradesh, India, 509002
Sponsors and Collaborators
SVS Institute of Dental Sciences
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Responsible Party: Dr R Viswa Chandra, Primary Investigator, SVS Institute of Dental Sciences Identifier: NCT04368650    
Other Study ID Numbers: SVSIDS/PERIO/4/2017
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr R Viswa Chandra, SVS Institute of Dental Sciences:
Sticky bone
Intrabony defects
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases