Alveolar Ridge Preservation Using Bone Allografts With a PRF Membrane Versus GBR: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change in alveolar ridge dimensions (height and width)
研究概览
简要总结
Following tooth extraction, physiologic remodeling of the alveolar ridge results in significant horizontal and vertical bone resorption, often accompanied by soft tissue collapse. These dimensional changes may complicate future implant placement and compromise esthetic and functional outcomes. Alveolar ridge preservation techniques have been introduced to limit post-extraction tissue loss by supporting bone regeneration and stabilizing the soft tissues. A previously conducted study has shown optimal wound healing of a guided bone regeneration technique by employing a non-submerged barrier membrane versus a socket seal technique employing a free gingival graft versus unassisted healing.
This prospective randomized controlled clinical trial aims to evaluate the effectiveness of alveolar ridge preservation using the combination of an allograft with either a platelet-rich fibrin (PRF) membrane, versus combination of an allograft with a barrier membrane versus spontaneous healing after tooth extraction. A total of fifty-one subjects will be randomly allocated into three treatment groups. Clinical and radiographic (periapical radiograph, CBCT) outcomes will be assessed at baseline, and 3 months post-extraction.
详细描述
Study Design
- Study Type: Interventional (Clinical Trial)
- Study Design: Prospective randomized controlled trial
- Estimated Enrollment: 51 participants
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single-blinded (Outcome Assessor)
- Primary Purpose: Treatment
Study Procedures
All study procedures will be performed according to a strictly standardized protocol and in a predefined chronological sequence to ensure the reliability and reproducibility of all measurements.
- Preoperative Phase 1.1 Participant Eligibility Assessment
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)
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. Requirement for extraction of a single tooth affected by periodontal disease. Presence of at least one adjacent tooth. Loss of the buccal alveolar bone wall involving up to 50% of the socket wall. Good general systemic health (American Society of Anesthesiologists ASA Physical Status I or II).
- •Satisfactory oral hygiene. Ability to understand the study procedures and provide written informed consent.
排除标准
- •Systemic diseases or medications known to affect bone or soft tissue healing (e.g., uncontrolled diabetes mellitus, osteoporosis treated with bisphosphonates, or immunosuppressive therapy).
- •Heavy smoking (>10 cigarettes/day). Pregnancy or breastfeeding. Presence of an acute infection or abscess at the extraction site. History of radiotherapy to the head and neck region. Inability or unwillingness to comply with the study protocol or attend scheduled follow-up visits.
研究组 & 干预措施
Control group-Spontaneous healing
Participants will undergo atraumatic tooth extraction followed by spontaneous socket healing without the placement of any grafting material or barrier membrane. Routine treatment of the extraction socket. Extraction of the tooth and suturing of the soft tissues with resorbable suture PGA 5/0 (polygalactic acid 5/0 sutures; PGA, medipac, Greece).
干预措施: Control group (Other)
Bone Allograft + Resorbable Guided Bone Regeneration (GBR) Membrane
- Atraumatic tooth extraction and socket debridement
- Placement of particulate bone allograft (ALO580-CTBA)into the extraction socket up to the level of the crestal bone
- Seal the socket orifice with a PLGA barrier membrane (Septodont RTR+ Membrane®) applied onto the crestal bone under the mucosal margins of the socket allowing healing by an open mode
- Suturing using resorbable sutures (PGA 5/0) (Medipac, Greece) without necessarily achieving primary wound closure
干预措施: Bone Allograft + Resorbable Guided Bone Regeneration Membrane (Procedure)
Bone Allograft + Autologous Platelet-Rich Fibrin (PRF) Membrane
- Atraumatic tooth extraction and socket debridement
- Placement of particulate bone allograft (ALO580-CTBA)as above into the extraction socket
- Preparation of autologous PRF according to standardized centrifugation protocol; application of a PRF membrane applied over the socket opening in an identical manner as the barrier membrane
- Resorbable sutures (PGA 5/0) (Medipac, Greece) without necessarily achieving primary wound closure
干预措施: Bone Allograft + Autologous Platelet-Rich Fibrin (PRF) Membrane (Procedure)
结局指标
主要结局
Change in alveolar ridge dimensions (height and width)
时间窗: • Time Frame: Baseline (extraction) to 3 months
1. Horizontal Alveolar Ridge Width Continuous quantitative variable. Measurement unit: millimeters (mm). Assessed using cone beam computed tomography (CBCT). Assessment time points: Baseline (T0; Visit 1) and 3 months postoperatively (T2). Outcome measure: Change in horizontal ridge width, calculated as T2 - T0. 2. Vertical Alveolar Ridge Height Continuous quantitative variable. Measurement unit: millimeters (mm). Assessed using CBCT and standardized periapical radiographs. Outcome measure: Change in vertical ridge height from T0 to T2. Measurement Tools Digital CBCT image analysis software. Standardized radiographic positioning guide to ensure reproducibility of radiographic measurements.
次要结局
- Gingival (Mucosal) Thickness(Assessment time points: Baseline (T0) and 3 months postoperatively (T2).)
- Width of Keratinized Tissue(Assessment time points: Baseline (T0) and 3 months postoperatively (T2))
- Early Wound Healing(Assessments will be performed immediately following tooth extraction (baseline) and at 7 and 14 days postoperatively.)
- Changes in the Clinical Attachment Level of Adjacent Teeth (Gingival Recession)(Assessment time points: Baseline (T0) and 3 months postoperatively (T2).)
研究者
Danae A. Apatzidou
DDS, PhD, Professor, Head of the Department, Director of the EFP accredited PG program "Periodontology & Implant Biology", Dept. of Preventive Dentistry, Periodontology & Implant Biology, School of Dentistry, Aristotle University of Thessaloniki
Aristotle University Of Thessaloniki