- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04372420
Bone Morphogenetic Protein-2 In Grade II Furcation Defects.
May 2, 2020 updated by: Dr R Viswa Chandra, SVS Institute of Dental Sciences
Recombinant Human Bone Morphogenetic Protein-2 In Absorbable Sponge Vs Platelet Rich Fibrin (PRF) In Grade Ii Furcation Defects - A Randomized Controlled Trial
The present study evaluated clinically and radiographically the regenerative potential of rhBMP-2 in absorbable sponge and PRF in Grade II furcation.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Telangana
-
Hyderabad, Telangana, India, 509002
- RV Chandra
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: RhBMP-2
RhBMP-2 belongs to TGF-β super family with osteoinductive property which is capable of promoting bone formation
|
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
Other Names:
|
Placebo Comparator: PLATELET RICH FIBRIN
Platelet rich fibrin(PRF) is a healing biomaterial with a great potential for bone and soft tissue regeneration, without any inflammatory reactions
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BONE FILL
Time Frame: 6 MONTHS
|
The evaluation of bone fill was performed after 6 months by using ImageJ® software.
|
6 MONTHS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 5, 2017
Primary Completion (Actual)
September 19, 2019
Study Completion (Actual)
October 10, 2019
Study Registration Dates
First Submitted
April 29, 2020
First Submitted That Met QC Criteria
April 29, 2020
First Posted (Actual)
May 4, 2020
Study Record Updates
Last Update Posted (Actual)
May 5, 2020
Last Update Submitted That Met QC Criteria
May 2, 2020
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SVSIDS/PERIO/3/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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