RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial

SVS Institute of Dental Sciences

Status and phase: Completed; Phase 2

Conditions: Periodontitis

Treatments: Procedure: PRF; Drug: BMP-2

Study type: Interventional

Funder types: Other

Identifiers

NCT04368650

SVSIDS/PERIO/4/2017

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Main treatment group

Experimental group

Description:

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.

Treatment:

Drug: BMP-2

Control

Active Comparator group

Description:

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.

Treatment:

Procedure: PRF