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

Sponsor

University of Baghdad (Other)

Overall Status

Recruiting

CT.gov ID

NCT05719181

Collaborator

(none)

Enrollment

Location

Arm

16.4

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Diabetes Mellitus Blood Disease	Biological: rhBMP-2	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

two groups; first group with protein , second group without (control)two groups; first group with protein , second group without (control)

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Effect of Recombinant Human Bone Morphogenetic Protein-2 With an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study of 6\12\2021 to20\4\2023

Actual Study Start Date :

Dec 6, 2021

Anticipated Primary Completion Date :

Mar 18, 2023

Anticipated Study Completion Date :

Apr 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: control group group consist of 16 patients with no protein application	Biological: rhBMP-2 Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge .

Arm

Intervention/Treatment

Experimental: control group

group consist of 16 patients with no protein application

Biological: rhBMP-2

Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge .

Outcome Measures

Primary Outcome Measures

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. [At the time of surgery ,all measurment (primary stability) was taken which represented the base line data.]
The topical application of rhBMP-2 in the osteotomy site has an effect through improve secondary stability of the dental implant.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Baghdad	Baghdad	Alresafa	Iraq	10011

Sponsors and Collaborators

University of Baghdad

Investigators

Principal Investigator: Adbullah Al Abbas, B.D.S, University of Baghdad, College of Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abdullah Ali Abbas, master student, University of Baghdad

ClinicalTrials.gov Identifier:

NCT05719181

Other Study ID Numbers:

528622

First Posted:

Feb 8, 2023

Last Update Posted:

Feb 8, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hematologic Diseases

Study Results

No Results Posted as of Feb 8, 2023