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Minimal Invasive Rehabilitation of Tooth Loss in the Anterior Segment

NCT ID: NCT01997827

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2025-10-31

Brief Summary

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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

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Conditions

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Unsatisfactory or Defective Restoration of Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metal-ceramic RBFDP

Treatment with a metal-ceramic RBFDP

Group Type ACTIVE_COMPARATOR

metal-ceramic RBFDP

Intervention Type DEVICE

Rehabilitation of tooth loss with a metal-ceramic RBFDP

all-ceramic RBFDP

Treatment with an all-ceramic RBFDP

Group Type EXPERIMENTAL

all-ceramic RBFDP

Intervention Type DEVICE

Rehabilitation of tooth loss with an all-ceramic RBFDP

Interventions

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metal-ceramic RBFDP

Rehabilitation of tooth loss with a metal-ceramic RBFDP

Intervention Type DEVICE

all-ceramic RBFDP

Rehabilitation of tooth loss with an all-ceramic RBFDP

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Dr. Wolfgang Bömicke

Dr. med. dent.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wolfgang Bömicke, Dr. med. dent.

Role: PRINCIPAL_INVESTIGATOR

Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg

Locations

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Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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S-083/2013a

Identifier Type: -

Identifier Source: org_study_id