Tooth Loss / RehabilitationSMBMPNCT07696299
Standard- and Micro-Dose rhBMP-2 for Implant Stability, Marginal Bone Loss, and Postoperative Sequelae: A Double-Blind Randomized Controlled Trial
A study testing Standard-dose rhBMP-2, Micro-dose rhBMP-2 and Sterile Normal Saline in people with Tooth Loss / Rehabilitation and Dental Implant, run by University of Baghdad at 1 site in Iraq.
Trial summary
This study will compare the effect of standard-dose and micro-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) with a placebo control on dental implant stability in the posterior mandible. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Tooth Loss / Rehabilitation, Dental Implant, Osseo-Integrated Implants
- What is being tested?
- Standard-dose rhBMP-2, Micro-dose rhBMP-2 and Sterile Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- Dec 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 20 to 55 years requiring a single dental implant for a single tooth missing in the posterior mandible (strictly limited to one implant per patient to prevent clustering effects and intra-subject correlation).
- Patients must be systemically healthy or medically well-controlled, categorized as ASA I or ASA II according to the American Society of Anesthesiologists classification.
- Surgical sites must exhibit D2 or D3 bone quality with adequate residual alveolar bone volume (minimum 6 mm width and 10 mm height).
- Patients must maintain optimal oral hygiene, suitable for a prosthetically driven implant treatment workflow.
Who cannot join
- Patients presenting with uncontrolled systemic conditions (e.g., unmanaged diabetes mellitus, active osteoporosis).
- A history of radiotherapy or chemotherapy in the maxillofacial region. Current heavy smoking habits (>10 cigarettes per day). Active and untreated periodontal disease. Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
Dr. Mahdi Dental Clinic
Baghdad, Baghdad Governorate, 10001
omer Alhashimi, M.SC., +9647733380409, omerdentist2@gmail.com
omerdentist2@gmail.com
About this study
Official title: Comparative Evaluation of Standard- and Micro-Dose Recombinant Human BMP-2 on Implant Stability, Marginal Bone Loss, and Postoperative Sequelae: A Double-Blind Randomized Controlled Trial
This study will compare the effect of standard-dose and micro-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) with a placebo control on dental implant stability in the posterior mandible. Sixty patients requiring a single dental implant will be randomly assigned to one of three groups: standard-dose rhBMP-2, micro-dose rhBMP-2, or sterile saline only. Implant stability will be measured using Resonance Frequency Analysis at baseline, 2 weeks, 4 weeks, and 12 weeks. Marginal bone loss, peri-implant bone density, ectopic bone formation, and postoperative sequelae including swelling, pain, trismus, and soft tissue healing will also be evaluated during follow-up. The aim is to determine whether micro-dose rhBMP-2 can improve implant stability while reducing postoperative complications compared with the standard dose.
Read the detailed description
This prospective, double-blind, randomized controlled clinical trial is designed to evaluate the effect of locally applied recombinant human bone morphogenetic protein-2 (rhBMP-2) on peri-implant stability, marginal bone loss, peri-implant bone density, postoperative sequelae, and ectopic bone formation following dental implant placement in the posterior mandible.
Sixty systemically healthy adult patients requiring a single implant-supported restoration in the posterior mandible will be enrolled and randomly allocated in a 1:1:1 ratio into three parallel groups (20 participants per group). Group A will receive the standard dose of rhBMP-2 (0.1 mg), Group B will receive a micro-dose of rhBMP-2 (0.02 mg), and Group C will receive sterile saline as the placebo control. Randomization will be computer-generated, and an independent assistant will prepare identical coded syringes to maintain allocation concealment. Patients, the operating surgeon, the clinical outcome assessor, and the statistician will remain blinded until completion of the final statistical analysis.
All implants will be placed by the same surgeon using the MegaGen AnyRidge implant system following a standardized surgical protocol. The allocated solution will be delivered into the prepared implant osteotomy immediately before implant insertion. Healing abutments will be connected at the time of surgery to allow non-invasive longitudinal resonance frequency analysis without disturbing the peri-implant tissues.
The primary outcome is peri-implant stability measured using Resonance Frequency Analysis (Osstell Beacon) at baseline, 2 weeks, 4 weeks, and 12 weeks after implant placement. Secondary outcomes include marginal bone loss and peri-implant bone density assessed using standardized CBCT at baseline, 6 months, and 12 months. Postoperative sequelae (pain, facial swelling, trismus, and early soft tissue healing) will be evaluated on postoperative days 1, 3, and 7. Ectopic bone formation will be assessed radiographically during follow-up. Statistical analyses will follow the intention-to-treat principle using repeated-measures and between-group analyses with statistical significance set at P < 0.05.
- Being tested
- Standard-dose rhBMP-2, Micro-dose rhBMP-2, Sterile Normal Saline
- Keywords
- rhbmp-2, Recombinant Human Bone Morphogenetic Protein-2, Dental Implant, Implant Stability, Micro-dose, Standard-dose, Osstell, Resonance Frequency Analysis, ISQ, Marginal Bone Loss, Peri-implant Bone Density, Posterior Mandible, Randomized Controlled Trial
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard-dose rhBMP-2Biological
Also called Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)
Standard-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) is locally applied into the implant osteotomy immediately before implant placement at the manufacturer's recommended dose to enhance osseointegration and implant stability.
Micro-dose rhBMP-2Biological
Micro-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) is locally applied into the implant osteotomy immediately before implant placement at a reduced dose to evaluate whether comparable implant stability can be achieved with fewer dose-related adverse effects.
Sterile Normal SalineDrug
Sterile normal saline is locally applied into the implant osteotomy immediately before implant placement as the placebo control.
| Study group | Role | What they receive |
|---|---|---|
| Standard-dose rhBMP-2 | Experimental | Participants will receive local application of the standard dose of recombinant human bone morphogenetic protein-2 (rhBMP-2) into the implant osteotomy immediately before dental implant placement. Receives: Biological: Standard-dose rhBMP-2 |
| Micro-dose rhBMP-2 | Experimental | Participants will receive local application of a micro-dose of recombinant human bone morphogenetic protein-2 (rhBMP-2) into the implant osteotomy immediately before dental implant placement. Receives: Biological: Micro-dose rhBMP-2 |
| Placebo Control | Placebo comparator | Participants will receive sterile normal saline applied into the implant osteotomy immediately before dental implant placement as the placebo control. Receives: Drug: Sterile Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-Implant Stability (Implant Stability Quotient [ISQ])
Peri-implant stability will be quantitatively assessed using Resonance Frequency Analysis (RFA) with the Osstell Beacon device. ISQ values will be recorded from two orthogonal directions (buccolingual and mesiodistal), and the mean value will be used for analysis to compare implant stability among the three study groups.
Measured: Baseline (immediately after implant placement), 2 weeks, 4 weeks, and 12 weeks after implant placement
Secondary outcomes (7)
Marginal Bone Loss
Marginal bone loss will be evaluated using standardized CBCT images. Linear measurements from the implant-abutment junction to the highest crestal bone level will be recorded at the mesial and distal aspects of each implant and compared among the three study groups.
Measured: Baseline (immediately after implant placement), 6 months, and 12 months after implant placement
Peri-Implant Bone Density
Peri-implant bone density will be evaluated using standardized CBCT scans. Bone density around the implant threads will be measured using Hounsfield Units (HU) or voxel gray values and compared among the three study groups to assess peri-implant bone remodeling.
Measured: Baseline (immediately after implant placement), 6 months, and 12 months after implant placement
Soft Tissue Swelling
Postoperative soft tissue swelling will be assessed using standardized linear facial measurements between predetermined anatomical landmarks. Measurements will be obtained preoperatively and postoperatively to compare the degree of swelling among the three study groups.
Measured: Baseline, postoperative days 1, 3, and 7
Pain Intensity (Visual Analog Scale [VAS])
Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants will record their pain scores at each assessment time point, and the results will be compared among the three study groups.
Measured: Daily during the first postoperative week
Trismus (Maximum Interincisal Distance)
Trismus will be assessed by measuring the maximum interincisal distance (MID) between the incisal edges of the upper and lower central incisors using a calibrated digital caliper. Measurements will be obtained at each assessment time point and compared among the three study groups.
Measured: Baseline, postoperative days 1, 3, and 7
Soft Tissue Healing Index (Landry Index)
Early soft tissue wound healing will be assessed using the validated Landry, Turnbull and Howley Healing Index. The index evaluates tissue color, bleeding on palpation, granulation tissue, epithelialization of the incision margin, and suppuration, with scores ranging from 1 (very poor healing) to 5 (excellent healing).
Measured: Postoperative days 1, 3, and 7
Ectopic Bone Formation
Ectopic bone formation will be assessed radiographically using standardized CBCT images. The presence, location, and extent of ectopic bone formation around the implant healing abutment will be evaluated and compared among the three study groups.
Measured: 6 months and 12 months 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 posted10 Jul 2026
- Study startDec 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Loss / RehabilitationStudies 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
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to receive standard-dose rhBMP-2, micro-dose rhBMP-2, or placebo during dental implant placement. Each participant will remain in the assigned intervention group throughout the study.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer Tareq Mohammed, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696299
- Sponsor's protocol ID
- UOB-CD-PHD-2026-001
- Acronym
- SMBMP
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Standard- and Micro-Dose Recombinant Human BMP-2 on Implant Stability, Marginal Bone Loss, and Postoperative Sequelae: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07696299
- Acronym / sponsor ID
- SMBMP / UOB-CD-PHD-2026-001
- Keywords
- rhbmp-2, Recombinant Human Bone Morphogenetic Protein-2, Dental Implant, Implant Stability, Micro-dose, Standard-dose, Osstell, Resonance Frequency Analysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Jul 2026 (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 study will compare the effect of standard-dose and micro-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) with a placebo control on dental implant stability in the posterior mandible. Sixty patients requiring a single dental implant will be randomly assigned to one of three groups: standard-dose rhBMP-2, micro-dose rhBMP-2, or sterile saline only. Implant stability will be measured using Resonance Frequency Analysis at baseline, 2 weeks, 4 weeks, and 12 weeks. Marginal bone loss, peri-implant bone density, ectopic bone formation, and postoperative sequelae including swelling, pain, trismus, and soft tissue healing will also be evaluated during follow-up. The aim is to determine whether micro-dose rhBMP-2 can improve implant stability while reducing postoperative complications compared with the standard dose.
Detailed description
This prospective, double-blind, randomized controlled clinical trial is designed to evaluate the effect of locally applied recombinant human bone morphogenetic protein-2 (rhBMP-2) on peri-implant stability, marginal bone loss, peri-implant bone density, postoperative sequelae, and ectopic bone formation following dental implant placement in the posterior mandible.
Sixty systemically healthy adult patients requiring a single implant-supported restoration in the posterior mandible will be enrolled and randomly allocated in a 1:1:1 ratio into three parallel groups (20 participants per group). Group A will receive the standard dose of rhBMP-2 (0.1 mg), Group B will receive a micro-dose of rhBMP-2 (0.02 mg), and Group C will receive sterile saline as the placebo control. Randomization will be computer-generated, and an independent assistant will prepare identical coded syringes to maintain allocation concealment. Patients, the operating surgeon, the clinical outcome assessor, and the statistician will remain blinded until completion of the final statistical analysis.
All implants will be placed by the same surgeon using the MegaGen AnyRidge implant system following a standardized surgical protocol. The allocated solution will be delivered into the prepared implant osteotomy immediately before implant insertion. Healing abutments will be connected at the time of surgery to allow non-invasive longitudinal resonance frequency analysis without disturbing the peri-implant tissues.
The primary outcome is peri-implant stability measured using Resonance Frequency Analysis (Osstell Beacon) at baseline, 2 weeks, 4 weeks, and 12 weeks after implant placement. Secondary outcomes include marginal bone loss and peri-implant bone density assessed using standardized CBCT at baseline, 6 months, and 12 months. Postoperative sequelae (pain, facial swelling, trismus, and early soft tissue healing) will be evaluated on postoperative days 1, 3, and 7. Ectopic bone formation will be assessed radiographically during follow-up. Statistical analyses will follow the intention-to-treat principle using repeated-measures and between-group analyses with statistical significance set at P < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to receive standard-dose rhBMP-2, micro-dose rhBMP-2, or placebo during dental implant placement. Each participant will remain in the assigned intervention group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Standard-dose rhBMP-2 | Experimental | Biological: Standard-dose rhBMP-2Participants will receive local application of the standard dose of recombinant human bone morphogenetic protein-2 (rhBMP-2) into the implant osteotomy immediately before dental implant placement. |
| Micro-dose rhBMP-2 | Experimental | Biological: Micro-dose rhBMP-2Participants will receive local application of a micro-dose of recombinant human bone morphogenetic protein-2 (rhBMP-2) into the implant osteotomy immediately before dental implant placement. |
| Placebo Control | Placebo comparator | Drug: Sterile Normal SalineParticipants will receive sterile normal saline applied into the implant osteotomy immediately before dental implant placement as the placebo control. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 20 to 55 years requiring a single dental implant for a single tooth missing in the posterior mandible (strictly limited to one implant per patient to prevent clustering effects and intra-subject correlation).
- Patients must be systemically healthy or medically well-controlled, categorized as ASA I or ASA II according to the American Society of Anesthesiologists classification.
- Surgical sites must exhibit D2 or D3 bone quality with adequate residual alveolar bone volume (minimum 6 mm width and 10 mm height).
- Patients must maintain optimal oral hygiene, suitable for a prosthetically driven implant treatment workflow.
Key exclusion criteria (2 listed)
- Patients presenting with uncontrolled systemic conditions (e.g., unmanaged diabetes mellitus, active osteoporosis).
- A history of radiotherapy or chemotherapy in the maxillofacial region. Current heavy smoking habits (>10 cigarettes per day). Active and untreated periodontal disease. Pregnancy or lactation.
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 |
|---|---|---|
| Standard-dose rhBMP-2Also: Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)Standard-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) is locally applied into the implant osteotomy immediately before implant placement at the manufacturer's recommended dose to enhance osseointegration and implant stability. | Biological | Standard-dose rhBMP-2 |
| Micro-dose rhBMP-2Micro-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) is locally applied into the implant osteotomy immediately before implant placement at a reduced dose to evaluate whether comparable implant stability can be achieved with fewer dose-related adverse effects. | Biological | Micro-dose rhBMP-2 |
| Sterile Normal SalineSterile normal saline is locally applied into the implant osteotomy immediately before implant placement as the placebo control. | Drug | Placebo Control |
Primary outcome
Peri-Implant Stability (Implant Stability Quotient [ISQ])
Time frame: Baseline (immediately after implant placement), 2 weeks, 4 weeks, and 12 weeks after implant placement
Peri-implant stability will be quantitatively assessed using Resonance Frequency Analysis (RFA) with the Osstell Beacon device. ISQ values will be recorded from two orthogonal directions (buccolingual and mesiodistal), and the mean value will be used for analysis to compare implant stability among the three study groups.
7 secondary outcomes
Marginal Bone Loss
Time frame: Baseline (immediately after implant placement), 6 months, and 12 months after implant placement
Peri-Implant Bone Density
Time frame: Baseline (immediately after implant placement), 6 months, and 12 months after implant placement
Soft Tissue Swelling
Time frame: Baseline, postoperative days 1, 3, and 7
Pain Intensity (Visual Analog Scale [VAS])
Time frame: Daily during the first postoperative week
Trismus (Maximum Interincisal Distance)
Time frame: Baseline, postoperative days 1, 3, and 7
Soft Tissue Healing Index (Landry Index)
Time frame: Postoperative days 1, 3, and 7
Ectopic Bone Formation
Time frame: 6 months and 12 months after implant placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant confidentiality.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard-dose rhBMP-2, Micro-dose rhBMP-2 and Sterile Normal Saline in people with Tooth Loss / Rehabilitation and Dental Implant, run by University of Baghdad 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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 10 Jul 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact omer Alhashimi, M.SC. (+9647733380409, omerdentist2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-Implant Stability (Implant Stability Quotient [ISQ]) (time frame: Baseline (immediately after implant placement), 2 weeks, 4 weeks, and 12 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 10 Jul 2026.