Comparison of Peri-implant Tissue Stability Following Soft Tissue Augmentation Harvested From the Deep Palate or the Tuberosity Area: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- soft tissue volume change 0-3
研究概览
简要总结
This study will compare peri implant tissue stability following connective tissue graft harvested fromLateral Palate or the Tuberosity Area. As far as we know, it remains controversial whether peri-implant soft tissue stability could be achieved after soft tissue augmentation with the connective tissue graft from the tuberosity or the lateral palate. Soft tissue stability evaluated by intra oral scanner will be described as primary outcome.
详细描述
Ridge resorption is a common finding after tooth extraction. Recently, there is an increasing concern about this issue during implant-supported reconstruction in the esthetic zone. Although the previous studies supports the guided bone regeneration procedures for reconstruction of contour deficiencies, the replacement of the mineralized materials with the bone has been questioned. Therefore, recently, using connective tissue grafts instead of allogenic or xenogenic materials has been addressed.
The palate is routinely used as the donor site for harvesting the connective tissue graft. The graft can be harvested by de-epithelialized method or it can be harvested conventionally from deep palate during flap elevation. Another choice for harvesting the connective tissue graft is the tuberosity area, which can be used when you need small to moderate amount of soft tissue (around 1-2 implants). The connective tissues harvested from these sites have quite different characteristics, which might influence on the fate of the treatment in terms of the stability.
therefore, we decided to compare the stability of the grafts harvested from the deep palate or tuberosity.
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 (Investigator, 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
- 是
入选标准
- •more than 18 years old.
- •systemically and periodontally healthy patients.
- •need of single implant placement between two maxillary teeth.
- •need of tissue augmentation due to concavity or soft tissue thickness less than 2 millimetres .
- •more than 3 month after extraction.
- •full mouth plaque index lesser than 20%.
- •sufficient mesiodistal and buccolingual space.
- •At least 10 millimetres mesiodistal dimension in tuberosity.
- •sufficient implant primary stability.
- •at least 6 mm crestal ridge width.
排除标准
- •History of periodontitis and radiotherapy.
- •Need of horizontal ridge augmentation.
- •Previous soft tissue augmentation.
- •Heavy smoker( more than 10 cigarette per day)
- •Local or systemic conditions that would interfere with routine periodontal therapy.
研究组 & 干预措施
CTG from tuberosity
The connective tissue graft harvested from the tuberosity
干预措施: connective tissue graft (Procedure)
CTG from deep palate
The connective tissue graft harvested from the deep palate during flap elevation for implant placement
干预措施: connective tissue graft (Procedure)
结局指标
主要结局
soft tissue volume change 0-3
时间窗: from baseline (immediately before surgery) to 3 months
changes of soft tissue volume from baseline (immediately before surgery) to 3 months by intra oral scanner
soft tissue volume change 0-6
时间窗: from baseline (immediately before surgery) to 6 months
changes of soft tissue volume from baseline (immediately before surgery) to 6 months by intra oral scanner
soft tissue volume change 3-6
时间窗: from 3 months to 6 months
changes of soft tissue volume from 3 months to 6 months by intra oral scanner
次要结局
- The level of the pain by questionnaire through visual analogue scale(day 7)
- Palliative 0-7(immediately after surgery to 7 days later)
- Pink aesthetic score(6 months after surgery)
- Pink aesthetic score(3 months after surgery)
- The level of the pain by questionnaire through visual analogue scale(day 1)
- The level of the pain by questionnaire through visual analogue scale(immediately after surgery)
- The level of the pain by questionnaire through visual analogue scale(day 2)
- The level of the pain by questionnaire through visual analogue scale(day 3)
- The level of the pain by questionnaire through visual analogue scale(day 4)
- The level of the pain by questionnaire through visual analogue scale(day 5)
- The level of the pain by questionnaire through visual analogue scale(day 6)