A Resorbable Versus a Non-resorbable Bone Substitute at Immediate Post-extractive Single Implants Immediately Loaded: a Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in peri-implant bone volumes
研究概览
简要总结
This study compares two bone graft materials used when placing a dental implant right after tooth removal. One graft fully dissolves (GTO®), the other only partly (Apatos®).
The goal is to see which one better preserves bone and improves appearance around the implant.
详细描述
This multicenter, double-blind randomized controlled trial aims to compare the clinical, radiographic, and aesthetic outcomes of two xenogeneic bone substitutes, GTO® (fully resorbable) and Apatos® (partially resorbable), used in post-extractive sockets at the time of immediate implant placement.
Eligible patients are adults requiring a single-tooth extraction in the maxilla or mandible, followed by immediate implant placement.
The primary outcome is peri-implant bone volume changes over time, assessed using CBCT scans.
Secondary outcomes include implant and crown failure, implant stability, marginal bone level changes on periapical radiographs, and aesthetic outcomes evaluated using the pink esthetic score based on clinical photographs.
Patients will be followed up to 5 years after loading.
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
- Double (Participant, 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
- •Any patient requiring at least one single immediate post-extractive implant.
- •At least 18 year old, able to understand and to sign an informed consent
- •There must be sufficient bone to allow the placement of at least a 3.5 mm diameter and 8.5 mm long implant.
- •After tooth extraction there must be a potential gap of at least 2 mm from the buccal inner bone plate and the implant surface.
排除标准
- •General contraindications to implant surgery.
- •Immunosuppressed or immunocompromised patients.
- •Patients irradiated in the head and/or neck.
- •Uncontrolled diabetes.
- •Pregnancy or lactation.
- •Active periodontal disease
- •Poor oral hygiene and motivation.
- •Addiction to alcohol or drugs.
- •Psychiatric problems and/or unrealistic expectations
- •Patients with an acute infection (abscess) in the site intended for implant placement.
- •Patients unable to commit to a 5-year follow-up.
- •Patients treated or under treatment with intravenous amino-bisphosphonates.
- •patients referred only for implant placement if follow-ups cannot be done at treatment centre.
- •Patients participating in other studies, if the present protocol could not be fully adhered to. In case of doubts please contact the study coordinator.
研究组 & 干预措施
Resorbable Bone Substitute (GTO®)
Patients receive a fully resorbable bone substitute (GTO®) to fill the gap between the implant and the buccal bone wall during immediate post-extraction implant placement.
干预措施: GTO® (fully resorbable bone substitute) (Biological)
Partially Resorbable Bone Substitute (Apatos®)
Patients receive a partially resorbable bone substitute (Apatos®) to fill the gap between the implant and the buccal bone wall during immediate post-extraction implant placement.
干预措施: Apatos® (partially resorbable bone substitute) (Biological)
结局指标
主要结局
Changes in peri-implant bone volumes
时间窗: From enrollment to 5 years after implant loading
Volumetric changes in peri-implant tissues will be measured using limited-view CBCT scans taken at implant placement (baseline), 1 year, and 5 years after loading. The main endpoint is the difference in bone volume between baseline and 1 year.
次要结局
- Number of participants with crown or implant failure(From enrollment to 5 years after implant loading)
- Number of biological and biomechanical complications(From enrollment to 5 years after implant loading)
- Peri-implant marginal bone level changes(From enrollment to 5 years after implant loading)
- Aesthetic evaluation using the Pink Esthetic Score (0-14; higher scores = better outcome)(From enrollment to 5 years after implant loading)
研究者
Marco Esposito
Associate Professor
Marco Esposito