Safety and Clinical Performance of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Dental Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Rate of adverse events including reoperation following a complication and matrix removal
研究概览
简要总结
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Dental membrane used in dental surgery and to identify emerging risks in comparison to clinical data related to other treatment modalities.
The present study will be a prospective multicentric non-randomized and noncontrolled trial involving 50 patients followed for 24 months. The study will be conducted in France in 4 investigational centres.
详细描述
The study will be prospective, multicentric, single-arm observational (non-interventional) to evaluate the safety and performance of the CELLIS Dental membrane used in dental surgery.
All evaluations will be performed and products used according to the usual practice and the device IFU. CELLIS Dental will be used in accordance with its approved labelling.
The study will be conducted in France in 4 investigational centres including 50 patients scheduled for dental regeneration of soft tissue defects and development of soft tissues around teeth or implants.
Each patient will participate in one assessment period including a preoperative visit followed by the surgical procedure.
Patients will return for ambulatory visits on day 15 (+/- 5 days), on month 3 (+/- 2 weeks), on month 12 (+/- 2 weeks) and on month 24 (+/-2 weeks) post-surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patient aged ≥18 years,
- •Patient with an indication of keratinized soft tissue regeneration in the buccal cavity and/or keratinized soft tissue development around teeth or implants,
- •Patient being informed of his participation to the study and of the follow-up visits, and having given his written informed consent,
- •Patient being informed of the porcine origin of the device in advance of the procedure.
排除标准
- •Patient with known hypersensitivity to porcine materials,
- •Patient with acute or chronic infection or inflammation of the buccal cavity,
- •Patient with a general illness contra-indicated for implantology, periodontology, stomatology, cranio-maxillo-facial surgery,
- •Patient who is pregnant,
- •Patient who is incapacitated including protected and deprived of liberty person,
- •Patient having refused to participate in the study,
- •Patient refusing to return for the follow-up visits.
结局指标
主要结局
Rate of adverse events including reoperation following a complication and matrix removal
时间窗: From the surgical procedure throughout the entire 24-month follow-up period
Percentage
次要结局
- Evaluation of keratinized tissue width(Before surgery and at the 15-day and 3-month follow-up visits)
- Evaluation of periodontium thickness(Before surgery and at the 15-day and 3-month follow-up visits)
- Patient-reported pain using a visual analogue scale (VAS) scored from 0 to 10 (0=no pain; 10=worse pain).(At the 15-day, 3-month, 12-months and 24-months follow-up visits)
- Evaluation of the periodontal biotype(Before surgery and at the 15-day, 3-month, 12-months and 24-months follow-up visits)
- Patient satisfaction using a visual analogue scale (VAS) scored from 1 to 10 (1=unsatisfactory; 10=very satisfactory).(At the 15-day, 3-month, 12-months and 24-months follow-up visits)
- Surgeon aesthetic evaluation using a visual analogue scale (VAS) scored from 1 to 10 (1=unsatisfactory; 10=very satisfactory).(At the 15-day, 3-month, 12-months and 24-months follow-up visits)
- Device malfunctions-deficiencies: inadequacy of a medical device with respects to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labelling.(During the surgical procedure)