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

Clinical Performance of Porcelain-fused-to-metal and All-ceramic Resin-bonded Fixed Dental Prostheses in the Anterior Segment - a Randomized Controlled Pilot Study.

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.

Study Overview

• Status: Withdrawn
• Conditions: Unsatisfactory or Defective Restoration of Tooth
• Intervention / Treatment: Device: metal-ceramic RBFDP; Device: all-ceramic RBFDP

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success	restoration/abutment teeth without intervention according to the Fédération dentaire internationale (FDI) World dental federation criteria	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Color change of the abutment teeth	color change measured with a spectrophotometer expressed as ∆E	before tooth preparation, try-in of the framework, 1 week after cementation

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Investigators: Principal Investigator: Wolfgang Bömicke, Dr. med. dent., Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): October 1, 2025

Study Registration Dates

• First Submitted: November 18, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 28, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: S-083/2013a