Periosteal Sutures for Fixation of Composite Bone Graft Substitutes in Guided Bone Regeneration: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean buccal bone thickness (mm)
研究概览
简要总结
This randomized controlled clinical study, titled "Periosteal sutures for fixation of composite bone substitutes in guided bone regeneration: a randomized controlled clinical study," is being conducted at the Dental Unit of Hospital San Camilo and is sponsored/funded by SigmaGraft Biomaterials.
Purpose: The purpose of this study is to evaluate whether using a periosteal stabilization suturing technique improves outcomes in guided bone regeneration in the anterior maxilla when a composite bone graft substitute is used in conjunction with dental implant installation.
What participation involves: Participants will undergo clinical assessments and data collection by the research team according to the study protocol. As part of study-related imaging, participants will receive two cone-beam computed tomography (CBCT) scans, which involve exposure to ionizing radiation. To reduce radiation exposure, CBCT imaging will be performed at a private imaging center rather than using a conventional hospital CT scanner, and participants will use a lead apron for additional protection.
Potential benefits and risks: No direct benefit is expected for participants. However, the information gained may help improve future treatment approaches for patients requiring dental implants in the anterior maxilla with associated bone grafting procedures. The main risks described relate to exposure to ionizing radiation from CBCT imaging, and measures are in place to minimize this exposure.
Privacy and voluntary participation: Participant confidentiality will be protected. Study information will be stored securely with restricted access, and analyses will use de-identified data. Participation is voluntary, and participants may withdraw at any time without penalty or loss of benefits to which they are otherwise entitled.
详细描述
Guided bone regeneration (GBR) performed simultaneously with dental implant placement is a widely used approach to rebuild deficient alveolar ridges in the anterior maxilla (aesthetic zone). Predictable GBR relies on two key conditions: (1) the creation and maintenance of a stable regenerative compartment that protects the graft during early healing, and (2) tension-free primary soft-tissue closure capable of preserving that compartment throughout the regenerative phase. In clinical practice, graft and membrane stabilization is often achieved using titanium fixation devices (e.g., tacks or pins). While titanium tacks can provide rigid immobilization, they add hardware and procedural steps and may require removal during re-entry procedures. Periosteal mattress sutures have been proposed as a hardware-free alternative for stabilization by anchoring the graft and membrane apically and laterally, potentially limiting micromotion without the need for fixation devices.
This pilot randomized controlled clinical study evaluates whether a periosteal mattress suture technique provides postoperative buccal bone regeneration outcomes comparable to those achieved with titanium tacks when performing horizontal GBR in the anterior maxilla together with implant placement. The study is conducted in a hospital-based periodontics setting and was approved by the appropriate scientific ethics committee. All participants provide written informed consent prior to any study-related procedures, and participation is voluntary.
Study design and setting
This is a parallel-arm, randomized controlled clinical trial conducted at the Periodontics Clinic/Dental Unit of Hospital San Camilo. Eligible patients seeking implant therapy in the anterior maxilla are consecutively screened. Those who require horizontal GBR at the time of implant placement and meet eligibility criteria are invited to participate. Random allocation assigns participants to one of two stabilization approaches used during GBR:
Stabilization with titanium tacks (hardware fixation)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients seeking implant therapy in the anterior maxilla.
- •Patients requiring simultaneous guided bone regeneration (GBR) at the time of implant placement.
- •Implant placement performed in a healed ridge (not an immediate post-extraction site).
- •Able and willing to provide written informed consent.
排除标准
- •Uncontrolled diabetes.
- •Ongoing bisphosphonate therapy.
结局指标
主要结局
Mean buccal bone thickness (mm)
时间窗: 6 months
Buccal bone thickness is measured on CBCT at 1 mm, 3 mm, and 6 mm apical to the implant platform (linear distance from implant surface to the outer buccal bone contour). The primary outcome is the mean of these three measurements for each implant.
次要结局
未报告次要终点
研究者
Franco Cavalla
Prof. Dr. Franco Cavalla, Associate Professor
University of Chile