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
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：omer Alhashimi, M.SC.
- 電話番号：+9647733380409
- メール：omerdentist2@gmail.com
研究場所
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Baghdad Governorate
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Baghdad、Baghdad Governorate、イラク、10001
- Dr. Mahdi Dental Clinic
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コンタクト：
- omer Alhashimi, M.SC.
- 電話番号：+9647733380409
- メール：omerdentist2@gmail.com
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コンタクト：
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主任研究者：
- Omer AL-Hashimi, M.SC.
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参加基準
適格基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：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.
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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.
他の名前：
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実験的：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.
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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.
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プラセボコンパレーター：Placebo Control
Participants will receive sterile normal saline applied into the implant osteotomy immediately before dental implant placement as the placebo control.
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Sterile normal saline is locally applied into the implant osteotomy immediately before implant placement as the placebo control.
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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Peri-Implant Stability (Implant Stability Quotient [ISQ])
時間枠：Baseline (immediately after implant placement), 2 weeks, 4 weeks, and 12 weeks after implant placement
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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.
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Baseline (immediately after implant placement), 2 weeks, 4 weeks, and 12 weeks after implant placement
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Marginal Bone Loss
時間枠：Baseline (immediately after implant placement), 6 months, and 12 months after implant placement
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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.
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Baseline (immediately after implant placement), 6 months, and 12 months after implant placement
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Peri-Implant Bone Density
時間枠：Baseline (immediately after implant placement), 6 months, and 12 months after implant placement
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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.
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Baseline (immediately after implant placement), 6 months, and 12 months after implant placement
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Soft Tissue Swelling
時間枠：Baseline, postoperative days 1, 3, and 7
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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.
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Baseline, postoperative days 1, 3, and 7
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Pain Intensity (Visual Analog Scale [VAS])
時間枠：Daily during the first postoperative week
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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.
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Daily during the first postoperative week
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Trismus (Maximum Interincisal Distance)
時間枠：Baseline, postoperative days 1, 3, and 7
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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.
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Baseline, postoperative days 1, 3, and 7
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Soft Tissue Healing Index (Landry Index)
時間枠：Postoperative days 1, 3, and 7
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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).
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Postoperative days 1, 3, and 7
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Ectopic Bone Formation
時間枠：6 months and 12 months after implant placement
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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.
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6 months and 12 months after implant placement
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- UOB-CD-PHD-2026-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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