Standard- and Micro-Dose rhBMP-2 for Implant Stability, Marginal Bone Loss, and Postoperative Sequelae: A Double-Blind Randomized Controlled Trial
Starting soon · Not applicable · Has a placebo group
Conditions studied: Tooth Loss / Rehabilitation, Dental Implant, Osseo-Integrated Implants
In brief
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.
Key facts
- Study ID
- NCT07696299
- Run by
- University of Baghdad
- People needed
- 60
- Starts
- 2026-12-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-07-10
Who can join
Age: 20 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Dr. Mahdi Dental Clinic — Baghdad, Baghdad Governorate, Iraq
Full record on ClinicalTrials.gov
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