RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial

Phase 2

Completed

• Conditions: Periodontitis
• Interventions: Drug: BMP-2; Procedure: PRF

• Registration Number: NCT04368650
• Lead Sponsor: SVS Institute of Dental Sciences

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2017-12-05
• Primary Completion: 2019-09-20
• Study Completion: 2019-10-11
• Status Verified: 2020-04
• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-29
• Last Update Submitted: 2020-04-29
• Study First Posted: 2020-04-30
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Main treatment group	BMP-2	The in situ BMP-2 gel was prepared to a concentration of approximately 0.5 μg/ml and were stored at 4oC. The gel was then dispensed at site of interest in the study.
Control	PRF	In patients selected for control group, after degranulation, sticky bone was used to fill the defect. The surgical site was protected and covered using a periodontal dressing.

Primary Outcome Measures

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

Trial Locations

Locations (1)

SVS Institute of Dental Sciences, Mahabubnagar; 🇮🇳 Hyderabad, Andhra Pradesh, India