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

May 9, 2026 updated by: Aya Adil Saeed

Evaluating the Effect of Bone Morphogenetic Protein on Dental Implant Stability and Marginal Bone Level Following Immediate Implant Placement (Randomized Controlled Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • Baghdad Governorate
      • Baghdad, Baghdad Governorate, Iraq, 10001
        • University of Baghdad - College of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Healthy patients ≥18 years of either sex
  • Having a single or multiple unrestorable maxillary anterior and premolar teeth indicated for extraction
  • Jumping gap ≥2 mm
  • Apical bone ≥3 mm from the vertical structure beyond the apex
  • Willing to comply with the study and provide informed consent
  • Good oral hygiene

Exclusion Criteria:

  • Active infection or inflammation in implant area
  • Uncontrolled diabetes or coagulation disorders
  • Immunocompromised patients
  • Patients treated with bisphosphonate drugs
  • Psychiatric problems
  • Pregnant women
  • Medical conditions affecting bone healing
  • Clinical evidence of parafunctional habits
  • Heavy smokers (≥20 cigarettes/day)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: rhBMP-2 placement
rhBMP-2 is mixed with BCP bone graft and placed in the jumping gap after immediate dental implant placement.
Active Comparator: Control: standard immediate implant
Standard immediate dental implant placement procedure without application of Bone Morphogenetic Protein.
Device: conventional immediate implant
Standard immediate dental implant placement procedure without adding of Bone Morphogenetic Protein in the bone graft placed in the jumping gap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Stability Quotient (ISQ) measured by Resonance Frequency Analysis
Time Frame: Baseline and 16 weeks after implant placement
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal Bone Level (MBL) Changes around Dental Implants
Time Frame: Baseline and 16 weeks after implant placement
Radiographic assessment of marginal bone level (MBL) around dental implants using Cone Beam Computed Tomography (CBCT) at baseline and 16 weeks after implant placement.
Baseline and 16 weeks after implant placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aya Adil Saeed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2024

Primary Completion (Actual)

December 15, 2025

Study Completion (Actual)

January 15, 2026

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 9, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 991124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because this is an academic clinical study with a limited number of participants, and data will be used only for internal analysis within the University of Baghdad.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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