Soft Tissue Contour and Radiographic Evaluation of Ridge Preservation Using Different Techniques
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Soft tissue alternation
研究概览
简要总结
Soft tissue contour and radiographic evaluation of alveolar ridge preservation using different techniques
Background:
Following tooth extraction, the alveolar ridge undergoes an inevitable remodeling process which influences future implant therapy or prosthetic rehabilitation in the edentulous area. In an attempt to attenuate the loss of hard and soft tissue after tooth loss, alveolar ridge preservation (ARP) immediately after complete tooth extraction could minimize the need for ancillary ridge augmentation or soft tissue grafting. Different techniques and barrier membranes has been proposed to achieve the sealing of extraction socket.
Aim:
To investigate the effect of different techniques and barrier membranes for the soft tissue contour and morphological change of alveolar ridge after ARP
Methods:
The study was designed as a randomized controlled trial and recruited patients, who require ARP for the purpose of implant placement or prosthodontic rehabilitation. After the tooth extraction, patients were randomly allocated to one of the following groups: ridge preservation with a xenogeneic bone substitute and (a) spontaneous healing (control), (b) covered with a free palatal graft, (c) or covered with pedical palatal graft, (d) covered with a collagen membrane, (e) covered with a non-resorbable high-density polytetrafluoroethylene membrane. 2 weeks, 4 weeks, 12 weeks, and 24 weeks following tooth extraction and ARP, clinical profilometric and radiographic evaluations were performed to analyze the change of hard and soft tissue contour. Moreover, and the need for additional guided bone regeneration (GBR) or soft tissue augmentation were assessed prior implants or fixed prosthesis placement.
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)
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>20 years old
- •No contraindications for invasive dental procedures.
- •Not pregnant.
- •Teeth need to be extracted due to malocclusion or broken teeth.
- •Requires dental implant or denture fabrication after tooth extraction.
- •Healthy soft tissue (probing bleeding index <20%, plaque index <20%).
- •At least 2mm of keratinized gingiva on the buccal and lingual sides.
- •No need for simultaneous bone augmentation surgery during implant placement.
- •Willing to participate in and sign the consent form for this trial.
排除标准
- •Poor oral hygiene maintenance.
- •Uncontrolled periodontal disease.
- •Heavy smoker (smokes >20 cigarettes per day).
- •Uncontrolled diabetes.
- •Alcohol abuse.
- •Currently receiving medication treatment affecting wound healing (osteoporosis medication, radiation or chemotherapy).
结局指标
主要结局
Soft tissue alternation
时间窗: up to 12 months
cone-beam computed tomography data and STereoLithography files are superimposed to measure the soft tissue dimensions.
Hard tissue alternation
时间窗: up to 12 months
cone-beam computed tomography data and STereoLithography files are superimposed to measure the hard tissue dimensions.
次要结局
- Keratinized tissue width changes(up to 12 months)
- Visual Analogue Scale(14 days)
研究者
Cheng-En Sung
Assistant professor
Tri-Service General Hospital
