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NCT05719181 Clinical Trial

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

Hypertension Clinical Trial

— rhBMP-2  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05719181
Other study ID # 528622
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date December 6, 2021
Est. completion date April 20, 2023

Study information
Verified date January 2023
Source University of Baghdad
Contact Abdullah Al Abbas, B.D.S
Phone 07816357260
Email abdsin313@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 32
Est. completion date April 20, 2023
Est. primary completion date March 18, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 70 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• rhBMP-2
Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge .

Locations
Country Name City State
Iraq University of Baghdad Baghdad Alresafa

Sponsors (1)
Lead Sponsor Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
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