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Completed

NCT Number: NCT04368650

RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial

This study evaluated the regenerative potential of rhBMP-2 gel in intrabony defects when compared to sticky bone (control).

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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

Phase 2

Primary location

SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, Andhra Pradesh, 509002, India

About this study

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.

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 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.

Treatment and study plan

BMP-2

Drug

lyophilized Human Bone Morphogenetic Protein-2 was used as an active drug.

Other names: Experimental group

PRF

Procedure

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

Other names: Sticky bone group

Primary outcomes

  1. bone fill

    Time frame: 6 months

    bone fill evaluation done after 6 months by using ImageJ® software

Sponsors and collaborators

Lead sponsor

SVS Institute of Dental Sciences

Other

Registry information

Official study title

Evaluation of Rhbmp-2 And Sticky Bone in Intrabony Defects - A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 30, 2020
Registry last updated
Apr 30, 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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