Minimal Invasive Rehabilitation of Tooth Loss in the Anterior Segment

Unsatisfactory or Defective Restoration of Tooth Clinical Trial

— MIZE-F  

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01997827
• Other study ID #: S-083/2013a
• Status: Withdrawn
• Phase: N/A
• First received: November 18, 2013
• Last updated: December 1, 2015
• Start date: October 2013
• Est. completion date: October 2025

Study information

• Verified date: December 2015
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2025
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Unsatisfactory or Defective Restoration of Tooth

Intervention

Device:
• metal-ceramic RBFDP
Rehabilitation of tooth loss with a metal-ceramic RBFDP
• all-ceramic RBFDP
Rehabilitation of tooth loss with an all-ceramic RBFDP

Locations

Country	Name	City	State
Germany	Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg	Heidelberg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success	restoration/abutment teeth without intervention according to the Fédération dentaire internationale (FDI) World dental federation criteria	12 months	No
Secondary	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	No