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Completed

NCT Number: NCT04372420

Bone Morphogenetic Protein-2 In Grade II Furcation Defects.

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

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RV Chandra

Hyderabad, Telangana, 509002, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Experimental group

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

Other names: Control group

Primary outcomes

  1. BONE FILL

    Time frame: 6 MONTHS

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

Sponsors and collaborators

Lead sponsor

SVS Institute of Dental Sciences

Other

Registry information

Official study title

Recombinant Human Bone Morphogenetic Protein-2 In Absorbable Sponge Vs Platelet Rich Fibrin (PRF) In Grade Ii Furcation Defects - A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 4, 2020
Registry last updated
May 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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