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

Clinical Performance of Two Different Designs of All-ceramic Resin-bonded Fixed Dental Prostheses in the Posterior Segment - a Randomized Controlled Pilot Study.

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01997710
Acronym
MIZE-S
Enrollment
30
Registered
2013-11-28
Start date
2013-10-31
Completion date
2026-01-31
Last updated
2023-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unsatisfactory or Defective Restoration of Tooth

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 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.

Interventions

DEVICEall-ceramic inlay-retained RBFDP

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

Rehabilitation of tooth loss with an all-ceramic RBFDP

Sponsors

University Hospital Heidelberg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Success24 monthsrestoration/abutment teeth without intervention according to the Fédération dentaire internationale (FDI) World dental federation criteria

Secondary

MeasureTime frameDescription
restoration and antagonist wear12 months, 24 months, 36 monthswear (µm) of areas of interest at restoration and antagonists

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026