Prosthesis SurvivalNCT04374201
14y Prospective Study on Posterior Zirconia-based 3-unit FDPs
An observational study of Prosthesis Survival, run by Federico II University.
Trial summary
The main objective of the present prospective study is to evaluate the effectiveness of posterior zirconia FDPs after 14 years of function. Read more about this study
- Who is it for?
- Ages 21 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Survival
- What is being tested?
- 2 zirconia FDPs and 1 zirconia FDP
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2004to 31 Dec 2025
- 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 21 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In the present prospective clinical study, 37 patients (16 males, 21 females) needing at least 1 posterior FDP in the maxillary and/or the mandibular arches were recruited. The mean age of patients was 45.3 ± 11.6 years, with a minimum age of 21 and a maximum of 68 years. All patients were recruited at the Department of Prosthodontics of the University "Federico II" of Naples (Italy) from November 2004 to April 2005 (baseline) and provided a written informed consent
Who may be able to join
- good general health;
- ASA I or ASA II according to the American Society of Anesthesiologists;
- good periodontal health;
- Angle class I occlusal relationship;
- minimum of 20 teeth;
- good oral hygiene;
Show all 21Show fewer
- no evident signs of occlusal parafunctions and/or temporo-mandibular disorders.
- Moreover, the abutment teeth had to fulfill the following inclusion criteria:
- periodontal health (absence of tooth mobility, absence of furcation involvement);
- proper positioning in the dental arch (tooth axes adequate for a FDP);
- sufficient occlusal-cervical height of the clinical crown (≥4 mm) for the retention of a FDP;
- vital or endodontically treated to a clinically sound state;
- opposing natural teeth or fixed prostheses.
- Exclusion Criteria:- subjects preferring implant-supported prostheses;
- high caries activity;
- occlusal-gingival height of the abutment teeth <4 mm;
- reduced interocclusal distance or supraerupted opposing teeth;
- unfavorable crown-to-root ratio;
- severe wear facets, clenching, bruxism;
- presence of removable partial dentures;
- pregnancy or lactation.
Who cannot join
None listed.
About this study
Official title: Fourteen-year Evaluation of Posterior Zirconia-based Three-unit Fixed Dental Prostheses. A Prospective Clinical Study of All Ceramic Prosthesis
The main objective of the present prospective study is to evaluate the effectiveness of posterior zirconia FDPs after 14 years of function.
Read the detailed description
thirty-seven patients needing to replace either premolars or molars were involved and 48 3-unit zirconia-based FDPs were fabricated. Patients included in the present clinical study met specific inclusion criteria and clinical procedures were standardized.
Frameworks with a 9 mm2 cross section of the connectors and 0.6 mm minimum thickness of the retainers were made by means of Computer Aided Design/Computer Assisted Manufacturing. A resin cement was used to lute the restorations. The patients were recalled after 6 and 12 months and then yearly up to a total follow-up of 14 years. The United States Public Health Service criteria were used in order to examine technical and esthetic outcomes. Success and survival rates
- Conditions
- Prosthesis Survival
- Being tested
- 2 zirconia FDPs, 1 zirconia FDP
- Keywords
- zirconia, all ceramic prosthesis, prosthodontics, fixed dental prosthesis, prosthetic dentistry, prospective clinical study
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 zirconia FDPsOther
The United States Public Health Service criteria were used in order to examine technical and esthetic outcomes. Success and survival rates of the zirconia FDPs were calculated. The biological examination was performed analyzing both abutments and contralateral teeth.
1 zirconia FDPOther
The United States Public Health Service criteria were used in order to examine technical and esthetic outcomes. Success and survival rates of the zirconia FDPs were calculated. The biological examination was performed analyzing both abutments and contralateral teeth.
| Study group | Role | What they receive |
|---|---|---|
| 2 zirconia FDPs | 11 patients received 2 zirconia fixed dental prostheses Receives: Other: 2 zirconia FDPs | |
| 1 zirconia FDP | 26 patients received 1 zirconia FDP Receives: Other: 1 zirconia FDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival and success rate of zirconia FDPs
The 14-year cumulative survival rate of the zirconia FDPs was calculated by means of Kaplan-Meier analysis.
Measured: 14 years
Secondary outcomes (1)
Technical and aesthetic outcomes
The United States Public Health Service criteria were used in order to examine technical and esthetic outcomes.
Measured: 14 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Nov 2004
- Primary completion31 Dec 2019
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis SurvivalStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Zarone, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374201
- Sponsor's protocol ID
- 3Y-TZP Federico II
- Status last verified
- May 2020
- First submitted
- 24 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fourteen-year Evaluation of Posterior Zirconia-based Three-unit Fixed Dental Prostheses. A Prospective Clinical Study of All Ceramic Prosthesis
- ClinicalTrials.gov ID
- NCT04374201
- Acronym / sponsor ID
- 3Y-TZP Federico II
- Conditions
- Prosthesis Survival
- Keywords
- zirconia, all ceramic prosthesis, prosthodontics, fixed dental prosthesis, prosthetic dentistry, prospective clinical study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Nov 2004 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 May 2020 (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.
The main objective of the present prospective study is to evaluate the effectiveness of posterior zirconia FDPs after 14 years of function.
Detailed description
thirty-seven patients needing to replace either premolars or molars were involved and 48 3-unit zirconia-based FDPs were fabricated. Patients included in the present clinical study met specific inclusion criteria and clinical procedures were standardized.
Frameworks with a 9 mm2 cross section of the connectors and 0.6 mm minimum thickness of the retainers were made by means of Computer Aided Design/Computer Assisted Manufacturing. A resin cement was used to lute the restorations. The patients were recalled after 6 and 12 months and then yearly up to a total follow-up of 14 years. The United States Public Health Service criteria were used in order to examine technical and esthetic outcomes. Success and survival rates
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 zirconia FDPs | – | Other: 2 zirconia FDPs11 patients received 2 zirconia fixed dental prostheses |
| 1 zirconia FDP | – | Other: 1 zirconia FDP26 patients received 1 zirconia FDP |
Who may qualify
- Ages
- 21 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In the present prospective clinical study, 37 patients (16 males, 21 females) needing at least 1 posterior FDP in the maxillary and/or the mandibular arches were recruited. The mean age of patients was 45.3 ± 11.6 years, with a minimum age of 21 and a maximum of 68 years. All patients were recruited at the Department of Prosthodontics of the University "Federico II" of Naples (Italy) from November 2004 to April 2005 (baseline) and provided a written informed consent
Key inclusion criteria (21 listed)
- good general health;
- ASA I or ASA II according to the American Society of Anesthesiologists;
- good periodontal health;
- Angle class I occlusal relationship;
- minimum of 20 teeth;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 zirconia FDPsThe United States Public Health Service criteria were used in order to examine technical and esthetic outcomes. Success and survival rates of the zirconia FDPs were calculated. The biological examination was performed analyzing both abutments and contralateral teeth. | Other | 2 zirconia FDPs |
| 1 zirconia FDPThe United States Public Health Service criteria were used in order to examine technical and esthetic outcomes. Success and survival rates of the zirconia FDPs were calculated. The biological examination was performed analyzing both abutments and contralateral teeth. | Other | 1 zirconia FDP |
Primary outcome
Survival and success rate of zirconia FDPs
Time frame: 14 years
The 14-year cumulative survival rate of the zirconia FDPs was calculated by means of Kaplan-Meier analysis.
1 secondary outcome
Technical and aesthetic outcomes
Time frame: 14 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthesis Survival, run by Federico II University.
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 21 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Survival and success rate of zirconia FDPs (time frame: 14 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 5 May 2020.