RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04368650

Enrollment

Registered

2020-04-30

Start date

2017-12-05

Completion date

2019-10-11

Last updated

2020-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Keywords

Sticky bone, Intrabony defects, Regeneration

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.

Interventions

DRUGBMP-2

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

PROCEDUREPRF

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026