Clinical Performance of Long-span Fixed Partial Dentures

May 8, 2023 updated by: Dr. Wolfgang Bömicke, University Hospital Heidelberg

Clinical Performance of Long-span All-ceramic or Metal-ceramic Fixed Partial Dentures on Implants and/or Natural Teeth

Tooth-coloured fixed restorations are becoming increasingly popular with patients and dentists. If high-strength all-ceramics such as zirconia are used as the restoration material, a maximum of two adjacent missing teeth can be replaced with the aid of fixed partial dentures (FPDs). For the replacement of a missing anterior or posterior tooth by FPDs, a very good clinical performance similar to that of metal-based, ceramic-veneered restorations can be expected. However, evidence-based statements on the clinical performance of long-span all-ceramic FPDs are difficult because there are only very few studies on this topic, which are also inhomogeneous with regard to the study conditions. Randomized studies to compare monolithic (consisting only of the high-strength framework material) or partially veneered (weaker veneering ceramics in esthetically relevant tooth areas) all-ceramic and classic (completely veneered) metal-ceramic FPDs are lacking. The aim of the current explorative, prospective, randomized, two-arm clinical interventional study is therefore to compare the clinical performance of long-span FPDs (≥ 4 Pontics) made of monolithic / facially veneered zirconium dioxide with a gold standard (completely veneered cobalt chromium (CoCr)-based FPDs). Forty patients will be recruited. Once all inclusion criteria have been established, including the signed informed consent of the patients informed of the content, effort, advantages and disadvantages of the study, patients are assigned to the two study groups by stratified block randomization (main strata: tooth-supported / (tooth-)implant-supported). After placement of the restorations, follow-up examinations are performed after 1 week (baseline) and after half a year, one year, two years and three years. In addition to the main target criterion (veneering defects), further complications (related to FPDs or supporting tissues / structures) and parameters of oral health are recorded. Depending on the distribution and structure of the data, parametric and non-parametric statistics are used. Group differences with respect to the main target criterion ceramic defects are to be investigated by log-rank and chi-square tests. The significance level is set at α < 0.05. Since this is an explorative study, all p-values are descriptive.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Recruiting
        • Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The patient is at least 18 years old.
  • The patient has unrestricted legal capacity.
  • The patient has two posterior teeth (premolars and / or molars) that are to be replaced next to each other.
  • The patient is reliable and willing to take part in follow-up examinations regularly and over the entire study period (three years).
  • The information about the study has been understood by the patient and the signed declaration of consent has been received.

Exclusion Criteria:

  • Pregnancy and lactation
  • Local and / or systemic acute and / or chronic (also in the past) general medical diseases and conditions that contradict participation in the study and / or expose the patient to a higher risk in the case of participation in the study.
  • Severe bruxism diagnosed by a portable electrocardiomyography device (BruxOff) (> 4 bruxism episodes / night)
  • Reduced clinical crown height (< 5 mm before tooth preparation)

  • Limited periodontal health:

    • probing depths > 4 mm or = 4 mm and bleeding on probing,
    • Furcation involvement > I (first band of the periodontometer after Naber disappears completely)
    • Degree of loosening of the abutment teeth > Grade I (> 1 mm horizontal mobility)
  • Untreated endodontic problems of abutment teeth
  • Lack of antagonistic support from fixed dentures or natural teeth
  • Known allergies or intolerances to the materials used in the study
  • Lack of oral hygiene
  • Lack of compliance
  • Planned change of residence
  • Rejection of randomisation

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Monolithic / facially veneered zirconia
Participants receive one monolithic / facially veneered zirconia fixed partial denture.
Device: Monolithic / facially veneered zirconia fixed partial denture
Participant receives one monolithic / facially veneered zirconia fixed partial denture retained by either teeth, implants or teeth and implants for the replacement of two neighbouring posterior teeth.
Other: Completely veneered CoCr
Control group. Participants receive one completely veneered metal ceramic fixed partial denture.
Device: Completely veneered CoCr fixed partial denture
Participant receives one completely veneered CoCr fixed partial denture retained by either teeth, implants or teeth and implants for the replacement of two neighbouring posterior teeth.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time-dependent ceramic defect rate
Time Frame: 3 years
The time to the occurrence of a ceramic defect is used as the main target criterion. Ceramic defects are identified in a structured clinical examination after cleaning and drying of the restoration surface and with the aid of magnifying glasses.
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Restoration survival
Time Frame: 3 years
Time-dependent survival rate
3 years
Abutment-tooth survival
Time Frame: 3 years
Time-dependent survival rate of abutment teeth
3 years
Implant survival
Time Frame: 3 years
Time-dependent survival rate of implants
3 years
Restoration success
Time Frame: 3 years
Time-dependent complication-free survival rate of restorations
3 years
Abutment-tooth success
Time Frame: 3 years
Time-dependent complication-free survival rate of abutment teeth
3 years
Implant success
Time Frame: 3 years
Time-dependent complication-free survival rate of implants
3 years
Risk-factor analysis
Time Frame: 3 years
Identification of influencing factors (risk factors such as sex, the position of the fixed partial denture in the upper or lower jaw, a tooth or implant-supported design, and the activity of the masticatory muscles) for the occurrence of complications.
3 years
Gingival / mucosal, periodontal / periimplant health of the abutment teeth / implants
Time Frame: 3 years
The gingival / mucosal inflammation is evaluated categorically (0 - 3) on the basis of the gingival index (GI) according to Loe and Silness. Periodontal / periimplant health is assessed by measuring the pocket depth around teeth and implants using a millimeter-scaled periodontal probe and by simultaneously measuring the incidence of bleeding on probing (BOP) and suppuration.
3 years
Plaque accumulation
Time Frame: 3 years
The accumulation of dental / peri-implant plaque is determined categorically (0 - 3) on the basis of the Plaque Index (PI) according to Silness and Loe.
3 years
Patients' satisfaction with restoration esthetics
Time Frame: 3 years
Satisfaction with the esthetics of the restorations is assessed by the patient on a 6-point visual analogue scale.
3 years
Wear on the restoration and the natural opposing dentition
Time Frame: 3 years
Quantification of the clinical wear (vertical height loss and volume loss) that has occurred on the restorations and antagonistic material using 3D superimposed diagnostic models
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Heidelberg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ivoclar Vivadent AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wolfgang Bömicke, PD Dr. MSc., Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S-682/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings