RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial | NCT04368650

Studies
RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial

NCT04368650

Sponsor

SVS Institute of Dental Sciences

Status

Completed

Last Update Posted

Apr 30, 2020Actual

Enrollment

40Actual

Phase

Phase 2

Conditions

Periodontitis

Interventions

BMP-2
PRF

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2017Actual

Primary Completion Date

Sep 20, 2019Actual

Completion Date

Oct 11, 2019Actual

First Submitted Date

Apr 23, 2020

First Submission Date that Met QC Criteria

Apr 29, 2020

First Posted Date

Apr 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2020

Last Update Posted Date

Apr 30, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr R Viswa Chandra, Primary Investigator, SVS Institute of Dental SciencesPrincipal Investigator

Lead Sponsor

SVS Institute of Dental SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
BMP-2	Drug	lyophilized Human Bone Morphogenetic Protein-2 was used as an active drug.	Main treatment group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SVS Institute of Dental Sciences, Mahabubnagar		Hyderabad	Andhra Pradesh	509002	India

IPD Sharing Statement Module

Plan to Share IPD

Description

No plans to share IPD.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010518	Periodontitis

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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