Prospective, National, Multicentre and Observational Clinical Investigation of R.T.R.+ Membrane Used in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Septodont
- 入组人数
- 90
- 试验地点
- 18
- 主要终点
- Post-operative wound healing measured by the Early Wound-Healing Index
研究概览
简要总结
The goal of this observational study is to measure in real practice the performance and safety of RTR+Membrane, a synthetic dental membrane for guided tissue regeneration in periodontal or dental implant surgery. The main question it aims to answer is to measure the post-operative wound healing several months after surgery. Participants will be followed after their dental surgery via clinical examination and radiological and photos images.
详细描述
Participants are any adult patients with one of the 3 following dental treatments to be done with RTR+Membrane:
- post-extraction socket preservation,
- alveolar ridge augmentation,
- Guided Tissue Regeneration (GTR) during immediate implant placement.
Since it is a real-life evidence study in current practice, patients will be followed at their surgery and their follow-ups. Below are listed visits and type of data collected.
- V1 - Surgery: Demography, Medical history and concomitant treatments, Clinical/technical information (tooth extraction, surgery, membrane and grafting materials use), Clinical Exam, Photography, X-rays or Cone Beam Computed Tomography (CBCT)
- V2 - Early follow-up (including suture removal, if needed): Clinical Exam, Questionnaire, Photography
- V2bis - Early follow-up: Clinical Exam, Photography
- V3 - Late follow-up: Clinical Exam, Photography, X-rays or CBCT, Questionnaire
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult patient
- •Patient with one of the 3 following dental treatments to be done with the study device: post-extraction socket preservation, alveolar ridge augmentation, or Guided Tissue Regeneration (GTR) during immediate implant placement.
- •Patient affiliated or beneficiary of a social security system.
- •Patient has signed his/her informed consent form.
排除标准
- •Pregnancy or lactation
- •Active tissue infection at the implant site
- •Several dental treatments done simultaneously in non-contiguous dental zones
- •Heavy smoker (>10 cigarettes / day)
- •Patient receiving long-term corticosteroid therapy, anti-rejection drugs, bisphosphonates, head & neck radiotherapy or chemotherapy
- •Patient with chronic infections (such as osteomyelitis) at the surgical site
- •Patient with poorly controlled metabolic disorders (such as diabetes, osteomalacia, thyroid disorders)
- •Patient with an auto-immune disease
- •Patient under tutelage, vulnerable person, person without liberty, or unable to complete questionnaire independently
研究组 & 干预措施
Post-extraction socket preservation group
The 30 eligible patients are any male and female, adult patients with the following dental treatment to be done with the study device: Post-extraction socket preservation (not done concomitantly to implant placement).
干预措施: Preserving alveolar bone volume after tooth extraction (Procedure)
Alveolar ridge augmentation group
The 30 eligible patients are any male and female, adult patients with the following dental treatment to be done with the study device: Alveolar ridge augmentation (not done concomitantly to implant placement).
干预措施: Alveolar crest reconstruction (Procedure)
Guided Tissue Regeneration (GTR) during immediate implant placement group
The 30 eligible patients are any male and female, adult patients with the following dental treatment to be done with the study device: Guided Tissue Regeneration (GTR) during immediate implant placement
干预措施: Covering bone defects during immediate implant placement. (Procedure)
结局指标
主要结局
Post-operative wound healing measured by the Early Wound-Healing Index
时间窗: up to 6 months
For all groups The Early Wound-Healing Index (EHI) has the following best to worst scoring: (EHI) 1: complete flap closure without fibrin line in the interproximal area. (EHI) 2: complete flap closure with fine fibrin line in the interproximal area. (EHI) 3: complete flap closure with fibrin clot in the interproximal area. (EHI) 4: incomplete flap closure with partial necrosis of the interproximal tissue. (EHI) 5: incomplete flap closure with complete necrosis of the interproximal tissue. The EHI is evaluated at the Visit 3 (late post-surgery follow-up) for the primary outcome measure.
次要结局
- Post-operative wound healing measured by Early Wound-Healing Index(up to 14 days)
- Post-operative clinical exam(up to 6 months)
- Post-operative wound healing measured by Early Wound Healing Score(up to 14 days)
- Oral Health-Related Quality of Life measured by the Oral Health Impact Profile (OHIP-5 items)(up to 6 months)
- Radiological measurements on CBCT(up to 6 months)
- Radiological measurements on retro-alveolar radios(up to 4 months)
- Number of adverse device effects (at least possibly) related to study device(up to 6 months)