Tooth LossNCT07240493
BMP Effect on Implant Stability and Marginal Bone Level After Immediate Placement
A study testing rhBMP-2 placement and conventional immediate implant in people with Tooth Loss and Alveolar Ridge Resorption After Extraction, run by Aya Adil Saeed at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss, Alveolar Ridge Resorption After Extraction, Tooth Extraction
- What is being tested?
- rhBMP-2 placement and conventional immediate implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIraq
- Study dates
- 15 Dec 2024to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active infection or inflammation in implant area
- Uncontrolled diabetes or coagulation disorders
- Immunocompromised patients
- Patients treated with bisphosphonate drugs
- Psychiatric problems
- Pregnant women
Show all 9Show fewer
- Medical conditions affecting bone healing
- Clinical evidence of parafunctional habits
- Heavy smokers (≥20 cigarettes/day)
Trial locations and contacts
1 site in 1 country.
Iraq1 site
University of Baghdad - College of Dentistry
Baghdad, Baghdad Governorate, 10001
About this study
Official title: 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.
Read more
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.
- Being tested
- rhBMP-2 placement, conventional immediate implant
- Keywords
- immediate implant placement, Bone morphogenetic protein, rhBMP-2
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhBMP-2 placementBiological
rhBMP-2 is mixed with BCP bone graft and placed in the jumping gap after immediate dental implant placement.
conventional immediate implantDevice
Standard immediate dental implant placement procedure without adding of Bone Morphogenetic Protein in the bone graft placed in the jumping gap.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: rhBMP-2 placement |
| Control: standard immediate implant | Active comparator | Standard immediate dental implant placement procedure without application of Bone Morphogenetic Protein. Receives: Device: conventional immediate implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 16 weeks after implant placement
Secondary outcomes (1)
Marginal Bone Level (MBL) Changes around Dental Implants
Radiographic assessment of marginal bone level (MBL) around dental implants using Cone Beam Computed Tomography (CBCT) at baseline and 16 weeks after implant placement.
Measured: Baseline and 16 weeks after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Dec 2024
- Primary completion15 Dec 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aya Adil Saeed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aya Adil Saeed, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240493
- Sponsor's protocol ID
- 991124
- Status last verified
- May 2026
- First submitted
- 16 Nov 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Bone Morphogenetic Protein on Dental Implant Stability and Marginal Bone Level Following Immediate Implant Placement (Randomized Controlled Study)
- ClinicalTrials.gov ID
- NCT07240493
- Acronym / sponsor ID
- 991124
- Keywords
- immediate implant placement, Bone morphogenetic protein, rhBMP-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aya Adil SaeedUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: rhBMP-2 Group | Experimental | Biological: rhBMP-2 placementImmediate dental implant placement with application of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) with bone graft in jumping gap. |
| Control: standard immediate implant | Active comparator | Device: conventional immediate implantStandard immediate dental implant placement procedure without application of Bone Morphogenetic Protein. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Active infection or inflammation in implant area
- Uncontrolled diabetes or coagulation disorders
- Immunocompromised patients
- Patients treated with bisphosphonate drugs
- Psychiatric problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhBMP-2 placementrhBMP-2 is mixed with BCP bone graft and placed in the jumping gap after immediate dental implant placement. | Biological | Experimental: rhBMP-2 Group |
| conventional immediate implantStandard immediate dental implant placement procedure without adding of Bone Morphogenetic Protein in the bone graft placed in the jumping gap. | Device | Control: standard immediate implant |
Primary outcome
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.
1 secondary outcome
Marginal Bone Level (MBL) Changes around Dental Implants
Time frame: Baseline and 16 weeks after implant placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rhBMP-2 placement and conventional immediate implant in people with Tooth Loss and Alveolar Ridge Resorption After Extraction, run by Aya Adil Saeed at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Stability Quotient (ISQ) measured by Resonance Frequency Analysis (time frame: Baseline and 16 weeks after implant placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.