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RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial

NCT ID: NCT04368650

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-05

Study Completion Date

2019-10-11

Brief Summary

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

Detailed Description

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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.

Conditions

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Periodontitis

Keywords

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Sticky bone Intrabony defects Regeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Main treatment group

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.

Group Type EXPERIMENTAL

BMP-2

Intervention Type DRUG

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

Control

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.

Group Type ACTIVE_COMPARATOR

PRF

Intervention Type 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

Interventions

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BMP-2

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

Intervention Type DRUG

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

Intervention Type PROCEDURE

Other Intervention Names

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Experimental group Sticky bone group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SVS Institute of Dental Sciences

OTHER

Sponsor Role lead

Responsible Party

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Dr R Viswa Chandra

Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, Andhra Pradesh, India

Site Status

Countries

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India

Other Identifiers

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SVSIDS/PERIO/4/2017

Identifier Type: -

Identifier Source: org_study_id