Bone Morphogenetic Protein-2 In Grade II Furcation Defects.

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04372420
• Other study ID #: SVSIDS/PERIO/3/2017
• Status: Completed
• Phase: N/A
• Start date: December 5, 2017
• Est. completion date: October 10, 2019

Study information

• Verified date: December 2019
• Source: SVS Institute of Dental Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study evaluated clinically and radiographically the regenerative potential of rhBMP-2 in absorbable sponge and PRF in Grade II furcation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 10, 2019
• Est. primary completion date: September 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Furcation Defects
• Periodontitis

Intervention

Drug:
• RhBMP-2 absorbable sponge in grade II furcation
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

Procedure:
• PLATELET RICH FIBRIN in grade II furcation
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

Locations

Country	Name	City	State
India	RV Chandra	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
SVS Institute of Dental Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BONE FILL	The evaluation of bone fill was performed after 6 months by using ImageJ® software.	6 MONTHS