Bone Morphogenetic Protein-2 In Grade II Furcation Defects.

NCT ID: NCT04372420

Last Updated: 2020-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-05

Study Completion Date

2019-10-10

Brief Summary

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

Detailed Description

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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.

Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group A- RhBMP-2 absorbable sponge is placed in grade II furcation and Group B- PRF is placed in the grade II furcation
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
participant and outcome assessor are masked from the study

Study Groups

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RhBMP-2

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

Group Type ACTIVE_COMPARATOR

RhBMP-2 absorbable sponge in grade II furcation

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

PLATELET RICH FIBRIN in grade II furcation

Intervention Type 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

Interventions

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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

Intervention Type DRUG

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

Intervention Type PROCEDURE

Other Intervention Names

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Experimental group Control group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SVS Institute of Dental Sciences

OTHER

Sponsor Role lead

Responsible Party

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Dr R Viswa Chandra

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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RV Chandra

Hyderabad, Telangana, India

Site Status

Countries

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India

Other Identifiers

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SVSIDS/PERIO/3/2017

Identifier Type: -

Identifier Source: org_study_id

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