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

NCT07240493 | Active Not Recruiting

• 1 other identifier: 991124
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Implant Stability Quotient (ISQ) measured by Resonance Frequency Analysis

  Evaluation of implant stability using resonance frequency analysis (RFA) device to measure the Implant Stability Quotient (ISQ) at baseline and 16 weeks after implant placement.

  Baseline and 16 weeks after implant placement

Secondary Outcomes (1)

• Marginal Bone Level (MBL) Changes around Dental Implants

  Baseline and 16 weeks after implant placement

Study Arms (2)

Experimental: rhBMP-2 Group

EXPERIMENTAL

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

Biological: rhBMP-2 placement

Control: standard immediate implant

ACTIVE COMPARATOR

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

Device: conventional immediate implant

Interventions

rhBMP-2 placement BIOLOGICAL

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

Experimental: rhBMP-2 Group

conventional immediate implant DEVICE

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

Control: standard immediate implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Apical bone ≥ 3mm from the vertical structure showed in x-rays beyond the apex.
• \. Patients who are willing to comply the study and agree to provide their consent.
• \. Good to fair oral hygiene.

You may not qualify if:

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

Sponsors & Collaborators

• Aya Adil Saeed: lead

Study Sites (1)

University of Baghdad - College of Dentistry

Baghdad, Baghdad Governorate, 10001, Iraq

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 21, 2025
• Study Start: December 15, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)