Minimal Invasive Rehabilitation of Tooth Loss in the Post... | NCT01997710

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

NCT01997710

Sponsor

University Hospital Heidelberg

Status

Unknown status

Last Update Posted

Dec 18, 2023Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Unsatisfactory or Defective Restoration of Tooth

Interventions

all-ceramic inlay-retained RBFDP
all-ceramic RBFDP

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013Actual

Primary Completion Date

Jan 2026Estimated

Completion Date

Jan 2026Estimated

First Submitted Date

Nov 18, 2013

First Submission Date that Met QC Criteria

Nov 22, 2013

First Posted Date

Nov 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2023

Last Update Posted Date

Dec 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
all-ceramic inlay-retained RBFDP	Experimental	Treatment with an all-ceramic inlay-retained RBFDP	Device: all-ceramic inlay-retained RBFDP
all-ceramic RBFDP	Active Comparator	Treatment with an all-ceramic RBFDP	Device: all-ceramic RBFDP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
all-ceramic inlay-retained RBFDP	Device	Rehabilitation of tooth loss with an all-ceramic inlay-retained RBFDP	all-ceramic inlay-retained RBFDP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success	restoration/abutment teeth without intervention according to the Fédération dentaire internationale (FDI) World dental federation criteria	24 months

Secondary Outcomes

Measure	Description	Time Frame
restoration and antagonist wear	wear (µm) of areas of interest at restoration and antagonists	12 months, 24 months, 36 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wolfgang Bömicke, Priv.-Doz. Dr. med. dent.	Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg		Heidelberg	Baden-Wurttemberg	69120	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32924240	Result	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.
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