Standard- and Micro-Dose rhBMP-2 for Implant Stability, Marginal Bone Loss, and Postoperative Sequelae: A Double-Blind Randomized Controlled Trial

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат Standard-dose rhBMP-2
  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.
• Биопрепарат Micro-dose 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.
• Препарат Sterile Normal Saline
  Sterile normal saline is locally applied into the implant osteotomy immediately before implant placement as the placebo control.

Первичные конечные точки

• Peri-Implant Stability (Implant Stability Quotient [ISQ]) [Срок оценки: Baseline (immediately after implant placement), 2 weeks, 4 weeks, and 12 weeks after implant placement]

Вторичные конечные точки (7)

• Marginal Bone Loss [Срок оценки: Baseline (immediately after implant placement), 6 months, and 12 months after implant placement]
• Peri-Implant Bone Density [Срок оценки: Baseline (immediately after implant placement), 6 months, and 12 months after implant placement]
• Soft Tissue Swelling [Срок оценки: Baseline, postoperative days 1, 3, and 7]
• Pain Intensity (Visual Analog Scale [VAS]) [Срок оценки: Daily during the first postoperative week]
• Trismus (Maximum Interincisal Distance) [Срок оценки: Baseline, postoperative days 1, 3, and 7]
• Soft Tissue Healing Index (Landry Index) [Срок оценки: Postoperative days 1, 3, and 7]
• Ectopic Bone Formation [Срок оценки: 6 months and 12 months after implant placement]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Ирак · 1 центр

• Dr. Mahdi Dental Clinic — Baghdad

Идентификаторы

NCT: NCT07696299 · UOB-CD-PHD-2026-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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