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Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.

2026年11月8日 更新者:Carlos Pérez-Albacete Martínez、Universidad Católica San Antonio de Murcia

EVALUACIÓN MEDIANTE FLUJO DIGITAL DEL IMPACTO DE LAS TERAPIAS DE PRESERVACIÓN ALVEOLAR EN LA ESTABILIDAD DIMENSIONAL DE LOS TEJIDOS

The dimensional collapse of the alveolar ridge following tooth extraction represents a critical challenge for implant rehabilitation. This research proposes an alveolar ridge preservation (ARP) protocol based on the combination of a slow-resorbing alloplastic synthetic biomaterial and a polymer-based resorbable synthetic membrane. Through a digital workflow integrating cone-beam computed tomography (CBCT) and intraoral scanning (Carestream 3800), volumetric changes in hard and soft tissues will be monitored. The study will compare baseline conditions with outcomes at 4 months of healing, analyzing whether the use of the membrane ensures adequate support for the gingival phenotype and minimizes buccal bone plate resorption.

研究概览

研究类型

介入性

注册 (估计的)

28

阶段

  • 阶段2
  • 阶段1

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adult patients (>18 years of age) with full cognitive capacity to understand and sign the Informed Consent approved by the UCAM Ethics Committee (in accordance with the 2022-23 Regulation).
  • Presence of at least one non-restorable mandibular premolar (first or second) or first mandibular molar with a clear indication for extraction and subsequent implant-supported prosthetic rehabilitation.
  • Buccal Bone Plate Integrity: Clinically intact buccal bone wall following baseline clinical examination and tomographic confirmation (T0 CBCT), presenting a continuous residual thickness of at least 1 mm, with no evidence of bone dehiscences or fenestrations prior to surgery (Type 1 sockets according to the Elian / Juodzbalys classification).
  • Absence of Active Infectious Processes: Surgical site free of signs of acute or exacerbated chronic infection. This excludes the presence of active suppuration, productive fistulas, periodontal abscesses, or extensive osteolytic periapical lesions (>2 mm in radiographic diameter) that could alter tissue pH or destabilize the biomaterial.
  • Adequate or stabilized general periodontal health, defined by a Full-Mouth Plaque Score (FMPS) ≤ 20% and Full-Mouth Bleeding Score (FMBS) ≤ 20%.

Exclusion Criteria:

  • Patients with uncontrolled systemic medical conditions that compromise bone or mucosal healing (e.g., Diabetes Mellitus with HbA1c >7%, severe calcium metabolism disorders, severe hepatopathies, or nephropathies).
  • Patients undergoing active treatment with drugs that alter bone remodeling, such as systemic bisphosphonates (oral or intravenous), denosumab, or prolonged systemic corticosteroid therapies.
  • History of previous radiotherapy in the head and neck region, or active medical oncology.
  • Heavy smokers (>10 cigarettes per day) due to the demonstrated deleterious impact of nicotine on angiogenesis and gingival collagen maturation, or substance abuse.
  • Pregnant or actively lactating women at the time of inclusion.
  • Any defect, intraoperative fracture, or unforeseen lesion detected in the buccal bone plate during the surgical extraction maneuver that compromises the baseline condition of alveolar wall integrity.
  • Patient inability to attend the rigorous follow-up appointments scheduled at 4 months, or severe claustrophobia preventing the acquisition of records via CBCT or intraoral scanning with the CS 3800.

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

  • 主要用途:卫生服务研究
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Experimental: Alveolar Ridge Preservation (ARP) utilizing a Slow-Resorbing Synthetic Alloplast and a

Following atraumatic tooth extraction and rigorous socket debridement, the alveolar defect will be grafted with a slow-resorbing synthetic alloplastic bone substitute. A resorbable polymer-based synthetic barrier membrane will be adapted over the graft material. The surgical site will be managed via a [flapped / flapless] approach and stabilizing sutures will be placed to allow for [primary / secondary] intention healing. No loading or prosthetic provisionalization will be applied over the grafted socket during the 4-month healing period.

This experimental intervention is distinguished by a fully synthetic, animal-free grafting protocol. Following a strictly flapless tooth extraction to preserve periosteal blood supply to the buccal bundle bone, the socket is grafted with a slow-resorbing synthetic alloplastic bone substitute, designed to act as a long-term space maintainer rather than a rapidly turning-over material. Crucially, the graft is covered by a polymer-based resorbable synthetic membrane, distinguishing it from standard protocols utilizing native or cross-linked collagen. The membrane is stabilized using non-resorbable cross-mattress sutures. To prevent distortion of the mucogingival junction, no periosteal releasing incisions are performed, and the site is left to heal by secondary intention with the membrane intentionally left exposed to the oral environment

其他:No Intervention: Unassisted Spontaneous Healing (Natural Blood Clot)

Following atraumatic tooth extraction and rigorous socket debridement, the alveolar defect will be left to heal spontaneously without the application of any bone graft material or barrier membrane. A natural blood clot will be allowed to form and stabilize within the socket. The surgical site will be managed strictly via a flapless approach, with stabilizing sutures placed only if necessary to secure the coagulum and achieve hemostasis. The socket will undergo unassisted secondary intention healing during the 4-month observation period prior to implant placement evaluation.

This control intervention is strictly distinguished by the complete absence of any ridge preservation biomaterials. It represents the baseline dimensional collapse of the alveolar ridge. Following a minimally invasive, flapless tooth extraction identical to the experimental arm, the socket is vigorously debrided but left unassisted to heal via a natural blood clot. To distinguish this true negative control from active comparators, no hemostatic agents (e.g., oxidized regenerated cellulose or gelatin sponges) are placed within the alveolus. Sutures are applied strictly to stabilize the existing gingival margins and secure the coagulum, allowing physiological secondary intention healing without any artificial space maintenance

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
Absolute Volumetric Change of the Alveolar Ridge Contour
大体时间:Baseline (Day 0, immediately post-extraction) and at 4 months post-operative.

The primary outcome is the total volumetric alteration of the alveolar ridge, encompassing combined hard and soft tissue dimensional changes. This will be quantified in cubic millimeters (mm^3) through a digital superimposition protocol. Baseline (Day 0) intraoral surface scans (STL) and Cone-Beam Computed Tomography (CBCT) DICOM files will be spatially aligned with 4-month (T1) postoperative STL and CBCT datasets using specialized image analysis software. A standardized Region of Interest (ROI) will be established using stable anatomical landmarks (e.g., adjacent teeth, hard palate) to calculate the absolute volume loss or gain

Baseline (Day 0, immediately post-extraction) and at 4 months post-operative.

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。

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11月1日

初级完成 (估计的)

2028年7月1日

研究完成 (估计的)

2028年10月1日

研究注册日期

首次提交

2026年10月10日

首先提交符合 QC 标准的

2026年10月10日

首次发布 (实际的)

2026年10月16日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月8日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • CE062612

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

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

在美国制造并从美国出口的产品

不

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