RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04368650
• Other study ID #: SVSIDS/PERIO/4/2017
• Status: Completed
• Phase: Phase 2
• Start date: December 5, 2017
• Est. completion date: October 11, 2019

Study information

• Verified date: April 2020
• Source: SVS Institute of Dental Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 11, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Drug:
• BMP-2
lyophilized Human Bone Morphogenetic Protein-2 was used as an active drug.

Procedure:
• PRF
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

Locations

Country	Name	City	State
India	SVS Institute of Dental Sciences, Mahabubnagar	Hyderabad	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
SVS Institute of Dental Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone fill	bone fill evaluation done after 6 months by using ImageJ® software	6 months