Back to resultsRhBMP-2 in Intrabony Defects - A Randomized Controlled Trial
Primary Purpose
Periodontitis
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
BMP-2
PRF
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis focused on measuring Sticky bone, Intrabony defects, Regeneration
Eligibility Criteria
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.
Sites / Locations
- SVS Institute of Dental Sciences, Mahabubnagar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Main treatment group
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
bone fill
bone fill evaluation done after 6 months by using ImageJ® software
Secondary Outcome Measures
Full Information
NCT ID
NCT04368650
First Posted
April 23, 2020
Last Updated
April 29, 2020
Sponsor
SVS Institute of Dental Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04368650
Brief Title
RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial
Official Title
Evaluation of Rhbmp-2 And Sticky Bone in Intrabony Defects - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 5, 2017 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
October 11, 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
This study evaluated the regenerative potential of rhBMP-2 gel in intrabony defects when compared to sticky bone (control).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Sticky bone, Intrabony defects, Regeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Main treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
BMP-2
Other Intervention Name(s)
Experimental group
Intervention Description
lyophilized Human Bone Morphogenetic Protein-2 was used as an active drug.
Intervention Type
Procedure
Intervention Name(s)
PRF
Other Intervention Name(s)
Sticky bone group
Intervention Description
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
Primary Outcome Measure Information:
Title
bone fill
Description
bone fill evaluation done 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 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.
Facility Information:
Facility Name
SVS Institute of Dental Sciences, Mahabubnagar
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
509002
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plans to share IPD.
Learn more about this trial
RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial
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