此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using BIOTECK Materials and OITECH Implant System (BIO-OI-TECHEIP)

2026年7月30日 更新者:Bioteck S.p.A.

Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using BIOTECK Materials and OITECH Implant System: A Randomized Controlled Clinical Study

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.

研究概览

地位

尚未招聘

研究类型

观察性的

注册 (估计的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Granada
      • Granada、Granada、西班牙、18071
        • Unidad Clínica del Máster de Odontología Integral Avanzada e Implantología. Departamento de Estomatología. Universidad de Granada

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Potential participants will be identified among patients treated at the University of Granada's Clinic for Advanced Comprehensive Dentistry and Implantology and Periodontology and Implants, either during routine diagnostic visits or through internal referrals. Patients who have a tooth-preferably an anterior tooth or premolar-for which extraction is clinically indicated and who express their intention to restore the area through the subsequent placement of a dental implant will be considered potential candidates.

描述

Inclusion Criteria:

  1. Age: ≥ 18 years.
  2. Good general health. Need for extraction of incisors, canines, or premolars due to caries, endodontic complications, root fracture, or prosthetic reasons.
  3. Presence of three intact alveolar walls following tooth extraction, with a defect in the vestibular wall (<50%).
  4. Need for treatment with single-tooth implants, with adjacent teeth and occlusal antagonists present.
  5. Sufficient available bone, as assessed by CBCT, for the placement of implants 3.6 mm in diameter and 10 mm in length.
  6. Periodontal health with intact or reduced periodontium. Full-mouth plaque and bleeding scores < 20%.
  7. Ability and willingness to follow the study procedures and instructions.

Exclusion Criteria:

  1. 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.
  2. Absence of adjacent teeth or opposing occlusal teeth.
  3. The missing tooth is a molar.
  4. More than one defect in the bone wall or a buccal defect >50%.
  5. Allergy or hypersensitivity to medications or any product used during the study.
  6. Regular use of tobacco (defined as >1 cigarette per day) or chewing tobacco, even within the 3 months prior to enrollment.
  7. Untreated periodontitis.
  8. Acute periapical or periodontal infection.
  9. Oral plaque and/or bleeding > 20%.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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.

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
Implant Stability Quotient (ISQ) by Resonance Frequecy Analysis (RFA)
大体时间: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.
At implant placement, at the second surgical phase (three months after implantation), and before prosthetic loading.
CBCT-assessed reduction in alveolar ridge height and width
大体时间: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.
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).
Percentage of newly formed bone, residual graft material, and bone marrow/connective tissue
大体时间: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.

Prior to implant placement

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Manuel Toledano, DDS, PhD、Universidad de Granada, Granada, Spain

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年6月30日

研究完成 (估计的)

2027年6月30日

研究注册日期

首次提交

2026年7月22日

首先提交符合 QC 标准的

2026年7月30日

首次发布 (实际的)

2026年8月5日

研究记录更新

最后更新发布 (实际的)

2026年8月5日

上次提交的符合 QC 标准的更新

2026年7月30日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2025_TIEMPOS_IMP

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

订阅