Patient and Operator Centered Outcomes in Harvesting Technique of Soft Tissue Graft: Guided Versus Non-Guided
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
- 1
- 主要终点
- Patient- and operator-centered outcomes will be assessed through visual analogue scale (VAS)
研究概览
简要总结
The goal of this clinical trial is to evaluate patient and operator centered outcomes after connective tissue graft harvesting with a fully digital workflow and compare this approach with a conventional one. The main questions it aims to answer are:
- Does it differ in patient- and operator-centered outcomes between the conventional and digital workflow?
- What is the difference in time efficiency between conventional and digital protocols? Researchers will compare digital guided versus conventional technique to choose adequately which protocol to use.
Participants will:
- Receive periodontal surgery to treat gingival recession site
- Visit the clinic after 2 weeks for suture removal & filling the survey
- The time will be recorded during the surgery
详细描述
50 sites will be included. All investigations will be carried out in accordance with the 1975 Helsinki Declaration, as revised in 2013 for ethical approval. All participants will provide written informed consent after receiving explanations on study objectives and procedures. Primary outcomes will be patient- and operator-centered outcomes. Patient- and operator-centered outcomes will be assessed through visual analogue scale (VAS), questionnaires containing self-developed questions about each phase of the treatment which will be administered at the end of each phase. The questionnaires will be administered as part of a survey which aimed to obtain information about the dental practices. Secondary outcomes will be time-efficiency by assessing workflow duration and number of appointments needed to complete the procedure. The treatment phases will include digital analysis of landmarks and design, of the guide and surgical phase (free gingival graft harvesting ). Time will be recorded in minutes. All the parameters will be recorded in the clinical chart by the same two operators not involved in the treatment after each phase was completed. The planned duration for the research will be 6 months.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •area need soft tissue augmentation around teeth either coronal or apical to recession
- •must have a general health showing no contraindications for oral surgery must be at least 20 years old.
- •patients also had to have good oral hygiene before the treatment
排除标准
- •signs or symptoms of bruxism or clenching
- •if they were suffering from uncontrolled systemic conditions
研究组 & 干预措施
guided soft tissue grafting technique
aguide was fabricated for harvesting the graft and patient and operater centered outcomes is recorded
干预措施: guided soft tissue grafting (Procedure)
non-guided soft tissue grafting technique
the graft was taken with the scalpel without guide
干预措施: non-guided soft tissue grafting technique (Procedure)
结局指标
主要结局
Patient- and operator-centered outcomes will be assessed through visual analogue scale (VAS)
时间窗: 6 months
Primary outcome will be patient- and operator-centered outcome. Patient- and operator-centered outcome will be assessed through visual analogue scale (VAS).
The questionnaires containing self-developed questions about each phase of the treatment
时间窗: 6 months
The questionnaires containing self-developed questions about each phase of the treatment which will be administered at the end of each phase. The questionnaires will be administered as part of a survey which aimed to obtain information about the dental practices.
次要结局
- The time-efficiency by assessing workflow duration(6 months)
- The number of appointments needed to complete the procedure(6 months)
研究者
safinaz saleh mohamed saeed
lecturer of periodontics
Tanta University