Standard- and Micro-Dose rhBMP-2 for Implant Stability, Marginal Bone Loss, and Postoperative Sequelae: A Double-Blind Randomized Controlled Trial (SMBMP)
Comparative Evaluation of Standard- and Micro-Dose Recombinant Human BMP-2 on Implant Stability, Marginal Bone Loss, and Postoperative Sequelae: A Double-Blind Randomized Controlled Trial
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：omer Alhashimi, M.SC.
- 电话号码：+9647733380409
- 邮箱：omerdentist2@gmail.com
学习地点
-
-
Baghdad Governorate
-
Baghdad、Baghdad Governorate、伊拉克、10001
- Dr. Mahdi Dental Clinic
-
接触：
- omer Alhashimi, M.SC.
- 电话号码：+9647733380409
- 邮箱：omerdentist2@gmail.com
-
接触：
-
首席研究员：
- Omer AL-Hashimi, M.SC.
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Standard-dose rhBMP-2
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.
|
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.
其他名称：
|
|
实验性的：Micro-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.
|
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.
|
|
安慰剂比较：Placebo Control
Participants will receive sterile normal saline applied into the implant osteotomy immediately before dental implant placement as the placebo control.
|
Sterile normal saline is locally applied into the implant osteotomy immediately before implant placement as the placebo control.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Peri-Implant Stability (Implant Stability Quotient [ISQ])
大体时间：Baseline (immediately after implant placement), 2 weeks, 4 weeks, and 12 weeks after implant placement
|
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.
|
Baseline (immediately after implant placement), 2 weeks, 4 weeks, and 12 weeks after implant placement
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Marginal Bone Loss
大体时间：Baseline (immediately after implant placement), 6 months, and 12 months after implant placement
|
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.
|
Baseline (immediately after implant placement), 6 months, and 12 months after implant placement
|
|
Peri-Implant Bone Density
大体时间：Baseline (immediately after implant placement), 6 months, and 12 months after implant placement
|
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.
|
Baseline (immediately after implant placement), 6 months, and 12 months after implant placement
|
|
Soft Tissue Swelling
大体时间：Baseline, postoperative days 1, 3, and 7
|
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.
|
Baseline, postoperative days 1, 3, and 7
|
|
Pain Intensity (Visual Analog Scale [VAS])
大体时间：Daily during the first postoperative week
|
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.
|
Daily during the first postoperative week
|
|
Trismus (Maximum Interincisal Distance)
大体时间：Baseline, postoperative days 1, 3, and 7
|
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.
|
Baseline, postoperative days 1, 3, and 7
|
|
Soft Tissue Healing Index (Landry Index)
大体时间：Postoperative days 1, 3, and 7
|
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).
|
Postoperative days 1, 3, and 7
|
|
Ectopic Bone Formation
大体时间：6 months and 12 months after implant placement
|
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.
|
6 months and 12 months after implant placement
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- UOB-CD-PHD-2026-001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.