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临床试验/NCT01997710
NCT01997710进行中(未招募)不适用

Clinical Performance of Two Different Designs of All-ceramic Resin-bonded Fixed Dental Prostheses in the Posterior Segment - a Randomized Controlled Pilot Study.

University Hospital Heidelberg2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
2
主要终点
Success

研究概览

简要总结

Tooth loss can be addressed by different rehabilitative strategies. Implant-supported crowns and conventional bridges (fixed dental prostheses [FDPs]) are well established treatment alternatives. Implant therapy is sometimes impossible, however, because of patient-related risk factors or economic issues. In such cases therapy with an FDP requires extensive removal of tooth structure to provide enough space for the restoration and to ensure mechanical retention if the abutment teeth are sound. Alternatives for rehabilitation requiring minor or no preparation of the anchoring teeth are desirable. Resin-bonded bridges meet this demand for minimal invasiveness and have been used clinically successfully. Sometimes, however, patients choose a conventional FDP over a resin-bonded one (RBFDP) for esthetic reasons since the adhesive wings, which are traditionally made of a cobalt-chromium alloy, might be exposed while speaking or smiling or account for a colour change of the abutment teeth. Such patients profit from an all-ceramic RBFDP. Today, the clinical performance of different all-ceramic RBFDP designs has not yet been evaluated under randomized controlled conditions. The aim of this pilot study is to calculate the sample size that allows us to accept the hypothesis that the two designs tested are similar regarding their clinical performance with adequate statistical power.

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
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • missing second premolar, or first molar, or second molar
  • regular patient of the department of prosthodontics of the university hospital of heidelberg
  • willingness to return for recall examinations on a regular basis
  • written informed consent
  • abutment teeth are vital or sufficiently endodontically treated
  • abutment teeth are periodontally stable
  • abutment teeth have only little or no defects of the hardsubstances

排除标准

  • Pregnancy or breastfeeding
  • medically compromised condition not allowing for standard dental treatment
  • Patient is not able to give written informed consent
  • alcohol or drug abuse
  • positive bruxism and parafunctions questionaire
  • Bite-Strip > 2
  • Attrition Score > 3
  • deep bite (Angle class II/2)
  • abutment tooth height < 4mm
  • missing canine or first premolar
  • gap size > 18 mm
  • untreated symptomatic periodontal or endodontic lesions
  • abutment tooth mobility > grade I
  • known allergies to materials used in this study
  • poor dental hygiene
  • planned change of residency

结局指标

主要结局

Success

时间窗: 24 months

restoration/abutment teeth without intervention according to the Fédération dentaire internationale (FDI) World dental federation criteria

次要结局

  • restoration and antagonist wear(12 months, 24 months, 36 months)

研究者

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

Dr. Wolfgang Bömicke

Dr. med. dent.

University Hospital Heidelberg

研究点 (2)

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