Minimal Invasive Rehabilitation of Tooth Loss in the Anterior Segment

NCT01997827 | Withdrawn DMC

• 1 other identifier: S-083/2013a
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Unsatisfactory or Defective Restoration of Tooth

Outcome Measures

Primary Outcomes (1)

• Success

  restoration/abutment teeth without intervention according to the Fédération dentaire internationale (FDI) World dental federation criteria

  12 months

Secondary Outcomes (1)

• Color change of the abutment teeth

  before tooth preparation, try-in of the framework, 1 week after cementation

Study Arms (2)

metal-ceramic RBFDP

ACTIVE COMPARATOR

Treatment with a metal-ceramic RBFDP

Device: metal-ceramic RBFDP

all-ceramic RBFDP

EXPERIMENTAL

Treatment with an all-ceramic RBFDP

Device: all-ceramic RBFDP

Interventions

metal-ceramic RBFDP DEVICE

Rehabilitation of tooth loss with a metal-ceramic RBFDP

metal-ceramic RBFDP

all-ceramic RBFDP DEVICE

Rehabilitation of tooth loss with an all-ceramic RBFDP

all-ceramic RBFDP

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Study Officials

• Wolfgang Bömicke, Dr. med. dent.

  Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. dent.

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 28, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2025
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

DE (1)