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Minimal Invasive Rehabilitation of Tooth Loss in the Posterior Segment (MIZE-S)

NCT ID: NCT01997710

Last Updated: 2023-12-18

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2026-01-31

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 different all-ceramic RBFDP designs 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 the two designs tested 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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all-ceramic inlay-retained RBFDP

Treatment with an all-ceramic inlay-retained RBFDP

Group Type EXPERIMENTAL

all-ceramic inlay-retained RBFDP

Intervention Type DEVICE

Rehabilitation of tooth loss with an all-ceramic inlay-retained RBFDP

all-ceramic RBFDP

Treatment with an all-ceramic RBFDP

Group Type ACTIVE_COMPARATOR

all-ceramic RBFDP

Intervention Type DEVICE

Rehabilitation of tooth loss with an all-ceramic RBFDP

Interventions

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all-ceramic inlay-retained RBFDP

Rehabilitation of tooth loss with an all-ceramic inlay-retained 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 second premolar, or first molar, or second molar
* 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
* missing canine or first premolar
* gap size \> 18 mm
* 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, Priv.-Doz. 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

References

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Bomicke W, Rathmann F, Pilz M, Bermejo JL, Waldecker M, Ohlmann B, Rammelsberg P, Zenthofer A. Clinical Performance of Posterior Inlay-Retained and Wing-Retained Monolithic Zirconia Resin-Bonded Fixed Partial Dentures: Stage One Results of a Randomized Controlled Trial. J Prosthodont. 2021 Jun;30(5):384-393. doi: 10.1111/jopr.13258. Epub 2020 Oct 4.

Reference Type RESULT
PMID: 32924240 (View on PubMed)

Bomicke W, Rathmann F, Rammelsberg P, Zenthofer A. Three-year performance of inlay-retained or wing-retained zirconia resin-bonded fixed partial dentures - results from a randomized clinical pilot study. J Dent. 2025 Aug;159:105807. doi: 10.1016/j.jdent.2025.105807. Epub 2025 May 6.

Reference Type DERIVED
PMID: 40339895 (View on PubMed)

Other Identifiers

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S-083/2013b

Identifier Type: -

Identifier Source: org_study_id