Standard- and Micro-Dose rhBMP-2 for Implant Stability, Marginal Bone Loss, and Postoperative Seq… (NCT07696299) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Standard- and Micro-Dose rhBMP-2 for Implant Stability, Marginal Bone Loss, and Postoperative Sequelae: A Double-Blind Randomized Controlled Trial
Iraq60 participantsStarted 2026-12
Plain-language 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. 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.
Who can participate
Age range
20 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.