Zirconium Dioxide Fixed Dental Prosthesis.

NCT06352983 | Completed

• 1 other identifier: 2014/11
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this clinical trial is to evaluate and compare bridges to replace one or two missing teeth in the mouth. The bridges will be made of two variants of ceramic material. We will evaluate the bridges for up to five years regarding technical and biological complications.

Conditions

Missing Teeth

Keywords

dental ceramics; zirconium dioxide; randomized controlled trial; monolithic; FDP

Outcome Measures

Primary Outcomes (2)

• Fractures

  Minor or major fractures of the fixed dental prosthesis material

  4 years; From cementation of the fixed dental prosthesis up to the final evaluation.

• De-bonding

  Loss of retention of the fixed dental prosthesis.

  4 years; From cementation of the fixed dental prosthesis up to the final evaluation.

Secondary Outcomes (4)

• Caries

  4 years; From cementation of the fixed dental prosthesis to the final evaluation.

• Endodontic

  4 years; From cementation of the fixed dental prosthesis to the final evaluation.

• Function

  4 years; From cementation of the fixed dental prosthesis to the final evaluation.

• Esthetics

  4 years. From cementation of the fixed dental prosthesis to the final evaluation.

Study Arms (2)

Veneered high-translucent zirconium dioxide fixed dental prosthesis

EXPERIMENTAL

Core material: high translucent zirconium dioxide (BruxZir, Glidewell, Newport Beach, Canada) Buccal veneer: porcelain (GC initial Zr, GC Corporation, Tokyo, Japan).

Procedure: Fixed dental prosthesis

Monolithic high-translucent zirconium dioxide fixed dental prosthesis

ACTIVE COMPARATOR

High translucent zirconium dioxide (BruxZir, Glidewell, Newport Beach, Canada)

Procedure: Fixed dental prosthesis

Interventions

Fixed dental prosthesis PROCEDURE

Fixed dentals prosthesis made out of high translucent zirconium dioxide with or without a porcelain veneer.

Monolithic high-translucent zirconium dioxide fixed dental prosthesis; Veneered high-translucent zirconium dioxide fixed dental prosthesis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who needed an FDP replacing one or two missing teeth in the posterior dentition (premolars and/or molars).

You may not qualify if:

• High caries activity Active periodontal disease Previously known history of repeated fractures of filings and/or reconstructions.

Sponsors & Collaborators

• Malmö University: lead

Study Sites (2)

Malmo university

Malmo, Skåne County, 214 21, Sweden

Location

Malmo university

Malmo, Skåne County, 21421, Sweden

Location

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Emma Gardell

  Malmo university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both participant, care providers, dental technicians and the investigator are blinded in the process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 8, 2024
• Study Start: December 20, 2017
• Primary Completion: September 27, 2019
• Study Completion: January 20, 2023
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)