- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05526547
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
Completed
Conditions
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
Observational
Enrollment (Actual)
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
-
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Bari
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Mola di Bari, Bari, Italy, 70042
- Giuseppe D'Albis
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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
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
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
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
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)
January 1, 2018
Primary Completion (Actual)
January 30, 2021
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
August 26, 2022
First Submitted That Met QC Criteria
August 30, 2022
First Posted (Actual)
September 2, 2022
Study Record Updates
Last Update Posted (Actual)
May 3, 2023
Last Update Submitted That Met QC Criteria
April 29, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID 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.
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