- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01997710
Minimal Invasive Rehabilitation of Tooth Loss in the Posterior Segment (MIZE-S) (MIZE-S)
December 15, 2023 updated by: Dr. Wolfgang Bömicke, University Hospital Heidelberg
Clinical Performance of Two Different Designs of All-ceramic Resin-bonded Fixed Dental Prostheses in the Posterior 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 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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Baden-Württemberg
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Heidelberg, Baden-Württemberg, Germany, 69120
- Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: all-ceramic inlay-retained RBFDP
Treatment with an all-ceramic inlay-retained RBFDP
|
Rehabilitation of tooth loss with an all-ceramic inlay-retained RBFDP
|
Active Comparator: all-ceramic RBFDP
Treatment with an 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
Time Frame: 24 months
|
restoration/abutment teeth without intervention according to the Fédération dentaire internationale (FDI) World dental federation criteria
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
restoration and antagonist wear
Time Frame: 12 months, 24 months, 36 months
|
wear (µm) of areas of interest at restoration and antagonists
|
12 months, 24 months, 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wolfgang Bömicke, Priv.-Doz. Dr. med. dent., Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2013
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
November 18, 2013
First Submitted That Met QC Criteria
November 22, 2013
First Posted (Estimated)
November 28, 2013
Study Record Updates
Last Update Posted (Estimated)
December 18, 2023
Last Update Submitted That Met QC Criteria
December 15, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- S-083/2013b
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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