Effect of Recombinant Human Bone Morphogenetic Protein-2... | NCT05719181

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 6, 2021Actual

Primary Completion Date

Mar 18, 2023Estimated

Completion Date

Apr 20, 2023Estimated

First Submitted Date

Dec 7, 2022

First Submission Date that Met QC Criteria

Jan 31, 2023

First Posted Date

Feb 8, 2023Actual

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

Jan 31, 2023

Last Update Posted Date

Feb 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Effect of Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study.

Detailed Description

The Primary outcome will be measuring the effect of rhBMP- 2/ACS in improving the secondary stability of dental implant by using RFA in comparison to control group.

Secondary outcome association of the effect of other factors (ridge dimension, bone density) on dental implant stability.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	Experimental	group consist of 16 patients with no protein application	Biological: rhBMP-2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rhBMP-2	Biological	Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge .	control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of Recombinant Human Bone Morphogenetic The Primary outcome will be measuring the effect of rhBMP- 2/ACS in improving the secondary stability of dental implant by using RFA in comparison to control group.	The topical application of rhBMP-2 in the osteotomy site has an effect through improve secondary stability of the dental implant.	At the time of surgery ,all measurment (primary stability) was taken which represented the base line data.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients have good oral hygiene.
Systemic healthy individuals ,Age more than18 years.
Healed edentulous area for at least 6 months after tooth extraction (delayed implant protocol).
Patients have at least two missing teeth in the jaw (canine to 1st molar area) indicated for the dental implant.

Exclusion Criteria:

Presence of systemic diseases preventing implantation.
Previous implantation or augmentation of the same region.
The need for additional bone augmentation procedures (such as maxillary sinus augmentation)
Partial or total edentulous ridge associated with a severe knife-edge ridge .
Acute infection or any pathological lesion a the implant site.
Allergy to one of the materials to be used during operation.
Pregnancy.
Radiation therapy, bisphosphonate drugs , Osteoradionecrosis.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abdullah Al Abbas, B.D.S	Contact	07816357260	+964	abdsin313@gmail.com
Abdullah Al Abbas, B.D.S	Contact	0781635726	+964	abdsin313@gmail.com

Overall Officials

Name	Affiliation	Role
Adbullah Al Abbas, B.D.S	University of Baghdad	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Baghdad	Recruiting	Baghdad	Alresafa	10011	Iraq

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D003920	Diabetes Mellitus
D006402	Hematologic Diseases

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D019485	Bone Morphogenetic Proteins
D055411	TGF-beta Superfamily Proteins
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors