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Completed

NCT Number: NCT07240493

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

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.

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Key information

Conditions

Tooth Loss Alveolar Ridge Resorption After Extraction Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases Tooth Extraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Baghdad - College of Dentistry

Baghdad, Baghdad Governorate, 10001, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

rhBMP-2 placement

Biological

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Aya Adil Saeed

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 21, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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