Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using BIOTECK Materials and OITECH Implant System: A Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Implant Stability Quotient (ISQ) by Resonance Frequecy Analysis (RFA)
研究概览
简要总结
This randomized controlled clinical study aims to compare two healing periods (4 vs 6 months) after extraction socket preservation using equine-derived enzymatically treated biomaterials (BIOTECK® system), prior to implant placement with the OITECH implant system. The study evaluates whether early implant placement at 4 months provides comparable or non-inferior outcomes to the conventional 6-month protocol in terms of primary implant stability, bone quality, and histological bone regeneration. Secondary outcomes include marginal bone level maintenance, peri-implant tissue health, implant survival, and the incidence of complications during follow-up. The goal is to generate clinical evidence to optimize the timing of implant placement without altering established treatment protocols.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥ 18 years.
- •Good general health. Need for extraction of incisors, canines, or premolars due to caries, endodontic complications, root fracture, or prosthetic reasons.
- •Presence of three intact alveolar walls following tooth extraction, with a defect in the vestibular wall (<50%).
- •Need for treatment with single-tooth implants, with adjacent teeth and occlusal antagonists present.
- •Sufficient available bone, as assessed by CBCT, for the placement of implants 3.6 mm in diameter and 10 mm in length.
- •Periodontal health with intact or reduced periodontium. Full-mouth plaque and bleeding scores < 20%.
- •Ability and willingness to follow the study procedures and instructions.
排除标准
- •Compromised health status. Presence of any systemic condition, such as uncontrolled diabetes mellitus, cancer, HIV, disorders that impair wound healing, chronic high-dose steroid therapy, intravenous and oral bisphosphonate therapy, metabolic bone diseases, a history of head and neck radiation, or any other immunosuppressive therapy that contraindicates oral surgical treatment.
- •Absence of adjacent teeth or opposing occlusal teeth.
- •The missing tooth is a molar.
- •More than one defect in the bone wall or a buccal defect >50%.
- •Allergy or hypersensitivity to medications or any product used during the study.
- •Regular use of tobacco (defined as >1 cigarette per day) or chewing tobacco, even within the 3 months prior to enrollment.
- •Untreated periodontitis.
- •Acute periapical or periodontal infection.
- •Oral plaque and/or bleeding > 20%.
研究组 & 干预措施
Test group
Guided bone regeneration procedure with Activabone® Mouldable Paste, as bone graft, the pericardium collagen membrane (Heart®) and stabilized with the collagen matrix Xenomatrix® (Bioteck S.p.A., Italy). Implant OITECH will be inserted 4 months after GBR procedure.
Control group
Guided bone regeneration procedure with Activabone® Mouldable Paste, as bone graft, the pericardium collagen membrane (Heart®) and stabilized with the collagen matrix Xenomatrix® (Bioteck S.p.A., Italy). Implant OITECH will be inserted 6 months after GBR procedure.
结局指标
主要结局
Implant Stability Quotient (ISQ) by Resonance Frequecy Analysis (RFA)
时间窗: At implant placement, at the second surgical phase (three months after implantation), and before prosthetic loading.
Implant stability will be assessed using resonance frequency analysis (RFA) with the Osstell IDx device (Osstell, Gothenburg, Sweden), which provides Implant Stability Quotient (ISQ) values. Two measurements will be obtained for each implant, one in the mesiodistal direction and one in the buccolingual/palatal direction. ISQ values range from 1 to 99, with higher values indicating greater implant stability. The same operator will perform all stability measurements.
CBCT-assessed reduction in alveolar ridge height and width
时间窗: One scan immediately after regenerative surgery (T0) and a second scan after a healing period of 6 or 4 months, prior to implant placement (T1).
Each patient will undergo Cone Beam Computed Tomography (CBCT) scans to assess changes in height and width. The cross-sections from T0 and T1 will be superimposed and aligned to determine the following reference lines. The percentage reduction in height and width will be calculated.
Percentage of newly formed bone, residual graft material, and bone marrow/connective tissue
时间窗: Prior to implant placement
The cylindrical bone sample extracted during implant site preparation will be analyzed. The sample will undergo resin embedding without decalcification and histological preparation for subsequent staining (toluidine blue, Von Kossa, and hematoxylin/eosin). Histomorphometric analysis will be performed using optical microscopy and image analysis software to quantify the percentage of each tissue component within the biopsy specimen.
次要结局
未报告次要终点