Comparative Efficacy of Three Alveolar Ridge Preservation Techniques for Volumetric Tissue Maintenance Following Tooth Extraction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Alveolar Ridge Dimensions
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of four post-extraction socket management approaches in preserving alveolar ridge dimensions following tooth extraction in adults requiring implant-supported rehabilitation in posterior regions.
The main questions it aims to answer are:
- Which treatment approach provides the greatest preservation of hard- and soft-tissue dimensions 12 weeks after tooth extraction?
- Does the use of a dense polytetrafluoroethylene (d-PTFE) membrane improve alveolar ridge preservation compared with approaches that do not use a membrane?
- Are there differences among the treatment groups regarding postoperative healing, complications, pain, and bone regeneration?
Researchers will compare spontaneous socket healing, autologous blood clot with d-PTFE membrane, autologous blood clot with leukocyte- and platelet-rich fibrin (L-PRF), and autologous blood clot with L-PRF plus d-PTFE membrane to determine which approach provides the best preservation of alveolar ridge dimensions and tissue healing.
Participants will:
- Undergo tooth extraction and be randomly assigned to one of four treatment groups.
- Receive clinical examinations, intraoral scans, photographs, and cone-beam computed tomography (CBCT) imaging at scheduled follow-up visits.
- Complete assessments of postoperative pain and oral health-related quality of life.
- Undergo implant placement 12 weeks after tooth extraction, including collection of a bone biopsy for histomorphometric analysis.
- Attend follow-up visits to evaluate peri-implant tissue health, marginal bone stability, and implant success up to 24 months after implant loading.
详细描述
Alveolar ridge dimensional changes following tooth extraction are a well-documented biological phenomenon that may compromise future implant placement and prosthetic rehabilitation. These alterations are primarily associated with physiological bone modeling and remodeling processes, particularly affecting the buccal bone plate, which is often thin and highly susceptible to post-extraction resorption.
Alveolar ridge preservation (ARP) procedures have been developed to reduce post-extraction hard- and soft-tissue volume loss. Numerous techniques have been described, including the use of barrier membranes, platelet concentrates, and grafting materials. However, substantial controversy remains regarding the necessity of membrane utilization, the role of leukocyte- and platelet-rich fibrin (L-PRF), and the optimal approach for maintaining alveolar ridge dimensions while minimizing treatment complexity and costs.
Dense polytetrafluoroethylene (d-PTFE) membranes have been proposed as an effective barrier for preserving extraction socket architecture, whereas L-PRF has been suggested to enhance soft-tissue healing and tissue regeneration through the release of autologous growth factors. Despite the widespread clinical use of both approaches, evidence comparing these treatment strategies remains limited.
This randomized controlled clinical trial aims to compare four post-extraction socket management protocols: spontaneous healing, autologous blood clot combined with a d-PTFE membrane, autologous blood clot combined with L-PRF, and autologous blood clot combined with both L-PRF and a d-PTFE membrane. The study will evaluate their effects on hard- and soft-tissue dimensional preservation, clinical healing, postoperative outcomes, histomorphometric bone formation, patient-reported quality of life, and long-term implant-related outcomes.
The findings of this study are expected to contribute to the development of evidence-based protocols for alveolar ridge preservation and to improve clinical decision-making in implant dentistry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors responsible for volumetric, radiographic, and histomorphometric analyses will be blinded to treatment allocation. Due to the nature of the surgical interventions, participants and treating clinicians cannot be blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years or older.
- •Requirement for tooth extraction with the possibility of subsequent implant-supported rehabilitation in the maxillary or mandibular premolar or molar regions.
- •Extraction sockets classified as Class I to Class Va according to the modified Cardaropoli classification.
- •American Society of Anesthesiologists (ASA) Physical Status I or II.
- •Ability to understand the study procedures and provide written informed consent.
排除标准
- •Current treatment with bisphosphonates or systemic corticosteroids.
- •History of head and neck radiotherapy.
- •Metabolic bone disorders.
- •Teeth presenting with acute infectious pathology at the time of extraction.
- •Pregnancy or breastfeeding.
- •Inability or unwillingness to attend scheduled follow-up visits.
- •Any medical or psychological condition that, in the opinion of the investigators, could interfere with study participation or data interpretation.
研究组 & 干预措施
Spontaneous Healing
Following atraumatic tooth extraction, the socket is left to heal spontaneously without the use of alveolar ridge preservation materials or barrier membranes.
干预措施: Spontaneous Healing (Procedure)
Arm 2: Blood Clot + d-PTFE Membrane
Following atraumatic tooth extraction, the socket is allowed to fill with an autologous blood clot and is covered with a dense polytetrafluoroethylene (d-PTFE) membrane to promote alveolar ridge preservation.
干预措施: d-PTFE Membrane (Procedure)
Arm 3: Blood Clot + L-PRF
Following atraumatic tooth extraction, the socket is treated with autologous leukocyte- and platelet-rich fibrin (L-PRF) in combination with the natural blood clot to support tissue healing and alveolar ridge preservation.
干预措施: d-PTFE Membrane (Procedure)
Arm 3: Blood Clot + L-PRF
Following atraumatic tooth extraction, the socket is treated with autologous leukocyte- and platelet-rich fibrin (L-PRF) in combination with the natural blood clot to support tissue healing and alveolar ridge preservation.
干预措施: Leukocyte- and Platelet-Rich Fibrin (L-PRF) (Procedure)
Blood Clot + L-PRF + d-PTFE Membrane
Following atraumatic tooth extraction, the socket is treated with autologous leukocyte- and platelet-rich fibrin (L-PRF) and covered with a dense polytetrafluoroethylene (d-PTFE) membrane to enhance tissue healing and alveolar ridge preservation.
干预措施: Leukocyte- and Platelet-Rich Fibrin (L-PRF) (Procedure)
结局指标
主要结局
Change in Alveolar Ridge Dimensions
时间窗: 12 weeks after tooth extraction
Change in hard- and soft-tissue dimensions of the extraction site between baseline (T1) and 12 weeks after tooth extraction (T3), assessed through three-dimensional volumetric analysis using superimposed CBCT and intraoral scan datasets. Hard-tissue measurements include horizontal ridge width at 1, 3, and 5 mm apical to the alveolar crest (HW-1, HW-3, HW-5), buccal plate width, and socket depth. Soft-tissue measurements include tissue thickness at 1, 3, and 5 mm apical to the alveolar crest (TH-1, TH-3, TH-5) and total occlusal soft-tissue height.
次要结局
- Oral Health-Related Quality of Life(Baseline to 24-28 weeks after tooth extraction)
- Histomorphometric Bone Formation(12 weeks after tooth extraction)
- Postoperative Pain(21 days after tooth extraction)
- Postoperative Complications(Up to 12 weeks after tooth extraction)
- Keratinized Tissue Width(Baseline to 12 weeks after tooth extraction)
- Bleeding on probing(12 and 24 months after implant loading)
- Peri-implant probing depth(12 and 24 months after implant loading)
- Radiographic marginal bone level(12 and 24 months after implant loading)