An interventional study of Standard-dose rhBMP-2 and Micro-dose rhBMP-2 in Tooth Loss / Rehabilitation, Dental Implant and Osseo-Integrated Implants, sponsored by University of Baghdad. Not yet recruiting at 1 site in Iraq. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by University of Baghdad · Not applicable, Interventional, and Treatment
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.
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.
165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.
This study's planned enrollment of 60 is above the median of 30 across 120 interventional studies indexed under Tooth Loss.
Browse Tooth Loss studies →University of Baghdad is the lead sponsor of 170 studies on the registry; 69 are open to participants now.
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Patients must be systemically healthy or medically well-controlled, categorized as 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:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Standard-dose rhBMP-2
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.
Biological: Micro-dose rhBMP-2
Participants will receive sterile normal saline applied into the implant osteotomy immediately before dental implant placement as the placebo control.
Drug: Sterile Normal Saline
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.
Also known as: Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)
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 saline is locally applied into the implant osteotomy immediately before implant placement as the placebo control.
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.
Time frame: Baseline (immediately after implant placement), 2 weeks, 4 weeks, and 12 weeks after implant placement
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 6 months and 12 months after implant placement
Plan to share: No — Individual participant data will not be shared to protect participant confidentiality.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Mar 2028, 15 months later.
Of 71 non-industry interventional studies with no phase under Tooth Loss, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 15 months is below that.
Counting every sponsor, half of 77 studies reached it within 28 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dibotermin alfa