Minimal Invasive Rehabilitation of Tooth Loss in the Anterior Segment

Not Applicable

Withdrawn

• Conditions: Unsatisfactory or Defective Restoration of Tooth
• Interventions: Device: all-ceramic RBFDP; Device: metal-ceramic RBFDP

• Registration Number: NCT01997827
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-28
• Primary Completion: 2015-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
all-ceramic RBFDP	all-ceramic RBFDP	Treatment with an all-ceramic RBFDP
metal-ceramic RBFDP	metal-ceramic RBFDP	Treatment with a metal-ceramic RBFDP

Primary Outcome Measures

Name	Time	Method
Success	12 months	restoration/abutment teeth without intervention according to the Fédération dentaire internationale (FDI) World dental federation criteria

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany