RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial

NCT04368650 | Completed Phase 2 DMC

• 1 other identifier: SVSIDS/PERIO/4/2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontitis

Keywords

Sticky bone; Intrabony defects; Regeneration

Outcome Measures

Primary Outcomes (1)

• bone fill

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

  6 months

Study Arms (2)

Main treatment group

EXPERIMENTAL

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.

Drug: BMP-2

Control

ACTIVE COMPARATOR

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.

Procedure: PRF

Interventions

BMP-2 DRUG

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

Also known as: Experimental group

Main treatment 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

Also known as: Sticky bone group

Control

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Medically compromised patients, Subjects who underwent radiotherapy or chemotherapy and smokers were excluded.

Sponsors & Collaborators

• SVS Institute of Dental Sciences: lead

Study Sites (1)

SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, Andhra Pradesh, 509002, India

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: Randomization involved the computerized generation of the allocation sequence in random permuted blocks (block randomization) and blinding was ensured by assigning the block of sites to study groups according to the specified sequence by a second operator who coded the two treatment sites selected from every patient by the first operator into the following groups

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 30, 2020
• Study Start: December 5, 2017
• Primary Completion: September 20, 2019
• Study Completion: October 11, 2019
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)