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Clinical Trials/NCT01997710
NCT01997710
Active, not recruiting
Not Applicable

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 Heidelberg1 site in 1 country30 target enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Unsatisfactory or Defective Restoration of Tooth
Sponsor
University Hospital Heidelberg
Enrollment
30
Locations
1
Primary Endpoint
Success
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
January 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Wolfgang Bömicke

Dr. med. dent.

University Hospital Heidelberg

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Success

Time Frame: 24 months

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

Secondary Outcomes

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

Study Sites (1)

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