Bone Morphogenetic Protein-2 In Grade II Furcation Defects.

NCT04372420 | Completed DMC

• 1 other identifier: SVSIDS/PERIO/3/2017
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• BONE FILL

  The evaluation of bone fill was performed after 6 months by using ImageJ® software.

  6 MONTHS

Study Arms (2)

RhBMP-2

ACTIVE COMPARATOR

RhBMP-2 belongs to TGF-β super family with osteoinductive property which is capable of promoting bone formation

Drug: RhBMP-2 absorbable sponge in grade II furcation

PLATELET RICH FIBRIN

PLACEBO COMPARATOR

Platelet rich fibrin(PRF) is a healing biomaterial with a great potential for bone and soft tissue regeneration, without any inflammatory reactions

Procedure: PLATELET RICH FIBRIN in grade II furcation

Interventions

RhBMP-2 absorbable sponge in grade II furcation DRUG

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

Also known as: Experimental group

RhBMP-2

PLATELET RICH FIBRIN in grade II furcation PROCEDURE

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

Also known as: Control group

PLATELET RICH FIBRIN

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy male and female patients of age group 20-55 yrs
• grade II furcation involvement and probing pocket depth of ≥5mm

You may not qualify if:

• 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

Sponsors & Collaborators

• SVS Institute of Dental Sciences: lead

Study Sites (1)

RV Chandra

Hyderabad, Telangana, 509002, India

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participant and outcome assessor are masked from the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Group A- RhBMP-2 absorbable sponge is placed in grade II furcation and Group B- PRF is placed in the grade II furcation

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 4, 2020
• Study Start: December 5, 2017
• Primary Completion: September 19, 2019
• Study Completion: October 10, 2019
• Last Updated: May 5, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)