BMP Effect on Implant Stability and Marginal Bone Level After Immediate Placement

NCT ID: NCT07240493

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-15
• Study Completion Date: 2026-01-31

Brief Summary

This randomized controlled clinical trial aims to evaluate the effect of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) on the stability and marginal bone level of dental implants following immediate placement.

patients requiring extraction of unrestorable tooth in upper incisors or premolar region will be randomly assigned into two groups: the experimental group will receive immediate implant placement with rhBMP-2 application, while the control group will receive immediate implant placement without rhBMP-2.

each group includes 16 immediate implants. Implant stability will be assessed using resonance frequency analysis (RFA) at baseline, and 16 weeks after implant placement. Marginal bone level changes will be evaluated radiographically using cone beam computed tomography (CBCT).

The study aims to determine whether the use of rhBMP-2 enhances osseointegration and reduces marginal bone loss compared with conventional immediate implant placement.

Conditions

Unrestorable Tooth Replaced by Immediate Implant With BMP

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental: rhBMP-2 Group

Immediate dental implant placement with application of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) with bone graft in jumping gap.

Group Type: EXPERIMENTAL

rhBMP-2 placement

Intervention Type: BIOLOGICAL

rhBMP-2 is mixed with BCP bone graft and placed in the jumping gap after immediate dental implant placement.

Control: standard immediate implant

Standard immediate dental implant placement procedure without application of Bone Morphogenetic Protein.

Group Type: ACTIVE_COMPARATOR

conventional immediate implant

Intervention Type: DEVICE

Standard immediate dental implant placement procedure without adding of Bone Morphogenetic Protein in the bone graft placed in the jumping gap.

Interventions

rhBMP-2 placement

rhBMP-2 is mixed with BCP bone graft and placed in the jumping gap after immediate dental implant placement.

Intervention Type: BIOLOGICAL

conventional immediate implant

Standard immediate dental implant placement procedure without adding of Bone Morphogenetic Protein in the bone graft placed in the jumping gap.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 1. Healthy patients ≥18 years of either sex, having a single or multiple unrestorable maxillary anterior and premolar teeth which are indicated for extraction, where a jumping gap is most likely to form (≥2mm) provides a reliable environment to study the local effects of rhBMP-2 in consistent and replicable conditions.

2. Apical bone ≥ 3mm from the vertical structure showed in x-rays beyond the apex.

3. Patients who are willing to comply the study and agree to provide their consent.

4. Good to fair oral hygiene.

Exclusion Criteria

• 1. Active infection or inflammation in implant area. 2. Medically compromised patients such as uncontrolled diabetes, coagulation disorders, immune compromised patient, patient treated with bisphosphate drugs, psychiatric problems, pregnant women, or any medical condition that affect bone healing.

3. Clinical evidence of parafunctional habits. 4. Heavy smokers (≥20 cigarettes a day).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aya Adil Saeed

OTHER

Sponsor Role: lead

Responsible Party

Aya Adil Saeed

principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Baghdad - College of Dentistry

Baghdad, Baghdad Governorate, Iraq

Countries

Iraq

Other Identifiers

991124

Identifier Type: -

Identifier Source: org_study_id