Standard- and Micro-Dose rhBMP-2 for Implant Stability, Marginal Bone Loss, and Postoperative Sequelae: A Double-Blind Randomized Controlled 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. 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.
Timeline
- Start
- 2026-12
- Primary completion
- 2028-03
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rhBMP-2 | Protein / enzyme biologic | 0.02 mg | Other |
| Subject | rhBMP-2 | Protein / enzyme biologic | 0.1 mg | Other |
Indications
No indication recorded.