Implant-supported Zirconia Partial Dentures With Cantilever

April 29, 2023 updated by: Giuseppe D'Albis, D'Albis Dental

Implant-supported Zirconia Fixed Partial Dentures Cantilevered in the Lateral-posterior Area

Fifteen partially edentulous patients received 34 implants and were provided 16 zirconia fixed partial prostheses (FPPs) with one cantilever extension replacing mandibular or maxillary missing posterior and lateral teeth. Patients were re-examined up to 4 years.

Study Overview

Status

Status

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

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.

Detailed Description

The investigators consecutively enrolled 15 patients who required dental implant rehabilitation with fixed dental prosthesis. All patients were attended at a private out-patient clinic from 2018 to 2021.The study was conducted in Italy and all procedures respect European laws and regulations.A diagnostic wax-up of the missing teeth was performed on digital casts for each case. Each case was designed using software planning the implant position in the distal part of the edentulous ridge where the bone conditions were more favorable.The surgical procedures were performed according to the protocols given by manufacturers.The implant site was prepared after raising a full-thickness flap. The implant was placed as designed in the digital planning with the support of a surgical guide.The patients were recalled 3-6 months after surgery for a pre-prosthetic evaluation. A healing abutment was placed, and implant stability was proven.Three weeks after second-stage surgery, the definitive digital impression was taken using an intraoral scanner. The prosthetic procedures were performed according to manufacturers' implant system recommendations. All prostheses were designed using CAD software with a connector cross-sectional area of at least 12 mm2. Monolithic zirconia fixed partial dentures were fabricated using a CAD-CAM unit from pre-sintered, pre-shade zirconia blanks . The fixed dentures were characterized with ceramic-based colors. The screw-retained zirconia prosthesis were subsequently inserted, and a check of the occlusion was performed.The patients get a baseline examination after 1-3 weeks of final prosthesis insertion. Aesthetics, proximal contacts, and occlusion were modified when needed following a careful examination. Patients were recalled at least once a year to assess the restorations functionally and aesthetically, peri-implant tissues, and implant health status. An individual maintenance program with regular dental hygiene sessions was performed during the entire study period for every patient, and an x-ray was taken at the 2-year follow-up.

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.
Observational

Enrollment (Actual)

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.
15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Bari
      • Mola di Bari, Bari, Italy, 70042
        • Giuseppe D'Albis

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

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who required dental implant rehabilitation with fixed dental prostheses.

Description

Inclusion Criteria:

  • Good health according to the System of the American Society of Anesthesiology
  • Aged older than 18 years
  • No general medical contraindication for implant therapy
  • Two or more missing teeth from the canine to the second molar
  • Good periodontal health or treated periodontitis

Exclusion Criteria:

  • Smoking more than 15 cigarettes a day
  • Untreated periodontitis
  • Pregnancy
  • Acute infections
  • Keratinized mucosal tissue less than 2 mm.

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

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
Prosthesis
Time Frame: 4 years
Evaluation of prosthetic clinical complication of the Fixed Partial Dentures: zirconia chipping (yes or not), zirconia Fracture (yes or not) , loosening of abutment screw (yes or not).
4 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
Implant
Time Frame: 4 years
Evaluation of biological complication implants related. Clinical outcome: mucositis(yes or not: blending on probing) , periimplantitis (yes or not: supuration and 3mm at least of marginal bone loosening), implants fractures (yes or not).
4 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.
D'Albis Dental

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 1, 2018

Primary Completion (Actual)

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.
January 30, 2021

Study Completion (Actual)

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.
June 30, 2022

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).
August 26, 2022

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.
August 30, 2022

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.
September 2, 2022

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 3, 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.
April 29, 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.
April 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.
  • cantilever

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