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临床试验/NCT05892016
NCT05892016Enrolling By Invitation不适用

Soft Tissue Contour and Radiographic Evaluation of Ridge Preservation Using Different Techniques

Tri-Service General Hospital2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2023年2月28日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cheng-En Sung

Assistant professor

Tri-Service General Hospital

研究点 (2)

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