Bone Morphogenetic Protein-2 In Grade II Furcation Defects.
Primary Purpose
Periodontitis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
RhBMP-2 absorbable sponge in grade II furcation
PLATELET RICH FIBRIN in grade II furcation
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
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
Sites / Locations
- RV Chandra
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
RhBMP-2
PLATELET RICH FIBRIN
Arm Description
RhBMP-2 belongs to TGF-β super family with osteoinductive property which is capable of promoting bone formation
Platelet rich fibrin(PRF) is a healing biomaterial with a great potential for bone and soft tissue regeneration, without any inflammatory reactions
Outcomes
Primary Outcome Measures
BONE FILL
The evaluation of bone fill was performed after 6 months by using ImageJ® software.
Secondary Outcome Measures
Full Information
NCT ID
NCT04372420
First Posted
April 29, 2020
Last Updated
May 2, 2020
Sponsor
SVS Institute of Dental Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04372420
Brief Title
Bone Morphogenetic Protein-2 In Grade II Furcation Defects.
Official Title
Recombinant Human Bone Morphogenetic Protein-2 In Absorbable Sponge Vs Platelet Rich Fibrin (PRF) In Grade Ii Furcation Defects - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 5, 2017 (Actual)
Primary Completion Date
September 19, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SVS Institute of Dental Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The present study evaluated clinically and radiographically the regenerative potential of rhBMP-2 in absorbable sponge and PRF in Grade II furcation.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
participant and outcome assessor are masked from the study
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RhBMP-2
Arm Type
Active Comparator
Arm Description
RhBMP-2 belongs to TGF-β super family with osteoinductive property which is capable of promoting bone formation
Arm Title
PLATELET RICH FIBRIN
Arm Type
Placebo Comparator
Arm Description
Platelet rich fibrin(PRF) is a healing biomaterial with a great potential for bone and soft tissue regeneration, without any inflammatory reactions
Intervention Type
Drug
Intervention Name(s)
RhBMP-2 absorbable sponge in grade II furcation
Other Intervention Name(s)
Experimental group
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
PLATELET RICH FIBRIN in grade II furcation
Other Intervention Name(s)
Control group
Intervention Description
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
Primary Outcome Measure Information:
Title
BONE FILL
Description
The evaluation of bone fill was performed after 6 months by using ImageJ® software.
Time Frame
6 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
RV Chandra
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
509002
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
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Bone Morphogenetic Protein-2 In Grade II Furcation Defects.
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