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Minimal Invasive Rehabilitation of Tooth Loss in the Anterior Segment (MIZE-F)

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ClinicalTrials.gov Identifier: NCT01997827
Recruitment Status : Withdrawn (Lack of Participants)
First Posted : November 28, 2013
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Wolfgang Bömicke, University Hospital Heidelberg

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 metal-based and all-ceramic RBFDPs 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 metal- and all-ceramic RBFDPs are similar regarding their clinical performance with adequate statistical power.

Condition or disease Intervention/treatment Phase
Unsatisfactory or Defective Restoration of Tooth Device: metal-ceramic RBFDP Device: all-ceramic RBFDP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Performance of Porcelain-fused-to-metal and All-ceramic Resin-bonded Fixed Dental Prostheses in the Anterior Segment - a Randomized Controlled Pilot Study.
Study Start Date : October 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: metal-ceramic RBFDP
Treatment with a metal-ceramic RBFDP
Device: metal-ceramic RBFDP
Rehabilitation of tooth loss with a metal-ceramic RBFDP

Experimental: all-ceramic RBFDP
Treatment with an all-ceramic RBFDP
Device: all-ceramic RBFDP
Rehabilitation of tooth loss with an all-ceramic RBFDP




Primary Outcome Measures :
  1. Success [ Time Frame: 12 months ]
    restoration/abutment teeth without intervention according to the Fédération dentaire internationale (FDI) World dental federation criteria


Secondary Outcome Measures :
  1. Color change of the abutment teeth [ Time Frame: before tooth preparation, try-in of the framework, 1 week after cementation ]
    color change measured with a spectrophotometer expressed as ∆E



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • missing central or lateral incisor
  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997827


Locations
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Germany
Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
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Principal Investigator: Wolfgang Bömicke, Dr. med. dent. Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg

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Responsible Party: Dr. Wolfgang Bömicke, Dr. med. dent., University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01997827     History of Changes
Other Study ID Numbers: S-083/2013a
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015