Single Tooth Extraction in Damaged Alveoli and Implant Site Development Randomized Controlled Clinical Trial Comparing Socket Preservation and Reconstruction Surgery to Spontaneous Healing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 主要终点
- Possibility to place dental implant
研究概览
简要总结
It is unclear what is the best approach to implant site development after tooth extraction when the pathology leading to extraction has damaged the alveolus. The main objective of this study is to assess if socket preservation and/or reconstruction surgery provides a clinical benefit in terms of ability to place an implant in a prosthetically guided position in such clinical conditions.
The PICO question therefore is:
In patients requiring single tooth extraction what is the benefit of socket preservation/reconstruction surgery with respect to spontaneous healing in terms of feasibility and ease of implant surgery?
详细描述
This will be a parallel group, standard of care-controlled, assessor-blind, randomized, multicenter, clinical trial.
The statistical design will be a superiority trial in terms of the primary outcome with reference to the standard of care control (spontaneous healing).
Primary outcome:
Possibility to place an implant in a prosthetically driven position with or without bone or soft tissue augmentation 16-20 weeks after tooth extraction, evaluated at planning with cone beam CT and confirmed at surgery.
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)
盲法说明
Independent outcome 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
- •Systemically healthy. No contraindications to elective oral surgery
- •All pathologies requiring single tooth extraction with adjacent teeth (or implant) with the presence of at least one third of the alveolus.
- •Evidence of subject ability to achieve good oral hygiene and control gingivitis in the whole of the dentition (FMPS<25% and FMBS<25%)
- •Ability to understand study procedures and to comply with them for the entire length of the study. Ability and willingness to give informed consent.
排除标准
- •Presence of frank purulence or acute abscess at the time of extraction
- •Presence of bone resorption of one or more walls of the alveolus extending to the apical third of the socket
- •Self reported current smoking exceeding 20 cigarettes/day or pipe or cigar smoking
- •Presence of medical contraindications to elective surgery
结局指标
主要结局
Possibility to place dental implant
时间窗: 16-20 weeks
The possibility to place a dental implant in a prosthetically driven position (with or without bone or soft tissue augmentation) 16-20 weeks after tooth extraction will be evaluated with a dedicated planning software using cone beam CT data and and digital scanning according to standard clinical practice
Surgeon's confirmation of the ability to place a dental implant
时间窗: 16-20 weeks
Confirmation during the surgery of the ability to actually insert the implant in a prosthetically driven position with or without the need for soft or hard-tissue augmentation.
次要结局
- Vertical change in bone height at the deepest point in the socket(16-20 weeks)
- Vertical change in bone height at the crest of adjacent teeth(16-20 weeks)
- Change in keratinized tissue width between baseline and insertion of prosthetic crown(16-20 weeks)
- Wound healing index(1-4 weeks)
- OHIP-14(1-2 weeks)
- Vertical change in bone height at the buccal bone crest(16-20 weeks)
- Radiographic bone changes(16-20 weeks)
- Need for additional bone augmentation at the time of implant placement (and/or implant uncovering, if submerged healing)(16-20 weeks)