About this 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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
Patients presenting with uncontrolled systemic conditions (e.g., unmanaged diabetes mellitus, active osteoporosis).
Trial design
Treatments tested in this trial
- Standard-dose rhBMP-2
- Micro-dose rhBMP-2
- Sterile Normal Saline