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

Phase 1

Recruiting

• Conditions: Diabetes Mellitus; Hypertension; Blood Disease
• Interventions: Biological: rhBMP-2

• Registration Number: NCT05719181
• Lead Sponsor: University of Baghdad

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.

Study Timeline

• Study Start: 2021-12-06
• Study First Submitted: 2022-12-07
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-31
• Last Update Submitted: 2023-01-31
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-03-18
• Study Completion: 2023-04-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
control group	rhBMP-2	group consist of 16 patients with no protein application

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Baghdad; 🇮🇶 Baghdad, Alresafa, Iraq