Partial-edentulismNCT05526547
Implant-supported Zirconia Partial Dentures With Cantilever
An observational study of Partial-edentulism, run by D'Albis Dental at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial-edentulism
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who required dental implant rehabilitation with fixed dental prostheses.
Who may be able to join
- 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
Who cannot join
- Smoking more than 15 cigarettes a day
- Untreated periodontitis
- Pregnancy
- Acute infections
- Keratinized mucosal tissue less than 2 mm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Partial-edentulism
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthesis
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).
Measured: 4 years
Secondary outcomes (1)
Implant
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).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Jan 2018
- Primary completion30 Jan 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial-edentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- D'Albis Dental
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe D'Albis, D'Albis Dental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526547
- Sponsor's protocol ID
- cantilever
- Status last verified
- Apr 2023
- First submitted
- 26 Aug 2022
- Last updated
- 3 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant-supported Zirconia Fixed Partial Dentures Cantilevered in the Lateral-posterior Area
- ClinicalTrials.gov ID
- NCT05526547
- Acronym / sponsor ID
- cantilever
- Conditions
- Partial-edentulism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- D'Albis DentalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who required dental implant rehabilitation with fixed dental prostheses.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Smoking more than 15 cigarettes a day
- Untreated periodontitis
- Pregnancy
- Acute infections
- Keratinized mucosal tissue less than 2 mm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Implant
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Partial-edentulism, run by D'Albis Dental at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthesis (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.