Single Tooth LostNCT02956174
Posterior CAD/CAM Cobalt-chromium Alloy Single Crowns: 4-year Prospective Clinical Study
A study testing Co-Cr single crown and Periodontal parameters in people with Single Tooth Lost, run by Federico II University.
Trial summary
Objectives - To evaluate the 4-year clinical outcomes of ceramic veneered Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) Co-Cr single crowns supported by natural teeth in posterior regions. Read more about this study
- Who is it for?
- Ages 21 to 68 years
- Conditions the study is for
- Single Tooth Lost
- What is being tested?
- Co-Cr single crown and Periodontal parameters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Jul 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- good general health
- American Society of Anesthesiologists (ASA) ASA I or ASA II condition; periodontal health
- Angle class I occlusal relationship
- minimum of 10 couples of opponent teeth
- good oral hygiene
- no evident signs of parafunctions and/or temporomandibular disorders.
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- periodontal health of abutment teeth (absence of tooth mobility, absence of furcation involvement);
- proper positioning of abutment teeth in the dental arch (tooth axis adequate for a SC)
- sufficient occlusal-cervical height of the clinical crown of abutment teeth (≥ 4 mm) for the retention of a SC
- vital or endodontically treated to a clinically sound state abutment teeth;
- abutment teeth opposing natural teeth.
Who cannot join
- high caries activity
- presence of periodontal disease on the abutment tooth
- occlusal-cervical height of the abutment tooth < 4 mm
- reduced interocclusal distance or supraerupted opposing teeth
- unfavorable crown-to-root ratio
- severe were facets, clenching and/or bruxism
Show all 9Show fewer
- presence of removable partial dentures (RPDs)
- pregnancy or lactation
- alcohol and/or drug addiction
About this study
Objectives - To evaluate the 4-year clinical outcomes of ceramic veneered Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) Co-Cr single crowns supported by natural teeth in posterior regions.
Material and methods - Eighty-nine patients were provided with 120 ceramic veneered CAD/CAM Co-Cr single crowns replacing either premolars and molars. Specific inclusion criteria were needed and tooth preparations were standardized and performed by 2 expert prosthodontists. CAD/CAM Co-Cr frameworks were fabricated and veneered with ceramics. The restorations were cemented using a eugenol-free zinc oxide luting agent. The patients were recalled after 1, 6, 12, 24, 36 and 48 months. The survival and success of the restorations were evaluated. The technical and esthetic outcomes were examined using the United States Public Health Service criteria. The biologic outcomes were analyzed at abutment and contralateral teeth and descriptive statistics were performed.
- Conditions
- Single Tooth Lost
- Being tested
- Co-Cr single crown, Periodontal parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-Cr single crownDevice
Periodontal parametersOther
| Study group | Role | What they receive |
|---|---|---|
| Co-Cr single crown | Experimental | Co-Cr single crown Receives: Device: Co-Cr single crown; Other: Periodontal parameters |
| Contralateral sound tooth | Active comparator | Contralateral sound tooth Receives: Other: Periodontal parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival percentage
Kaplan Meier analysis of survival of the prostheses
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 posted7 Nov 2016 (estimated)
- Study startMay 2012
- Primary completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Tooth LostStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 89 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
- NCT02956174
- Sponsor's protocol ID
- FZ_Co-Cr_2016
- Status last verified
- Nov 2016
- First submitted
- 30 Oct 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior CAD/CAM Cobalt-chromium Alloy Single Crowns: 4-year Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT02956174
- Acronym / sponsor ID
- FZ_Co-Cr_2016
- Conditions
- Single Tooth Lost
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2016 (actual)
- First posted
- 7 Nov 2016 (estimated)
- 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.
Objectives - To evaluate the 4-year clinical outcomes of ceramic veneered Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) Co-Cr single crowns supported by natural teeth in posterior regions.
Material and methods - Eighty-nine patients were provided with 120 ceramic veneered CAD/CAM Co-Cr single crowns replacing either premolars and molars. Specific inclusion criteria were needed and tooth preparations were standardized and performed by 2 expert prosthodontists. CAD/CAM Co-Cr frameworks were fabricated and veneered with ceramics. The restorations were cemented using a eugenol-free zinc oxide luting agent. The patients were recalled after 1, 6, 12, 24, 36 and 48 months. The survival and success of the restorations were evaluated. The technical and esthetic outcomes were examined using the United States Public Health Service criteria. The biologic outcomes were analyzed at abutment and contralateral teeth and descriptive statistics were performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Co-Cr single crown | Experimental | Device: Co-Cr single crown, Other: Periodontal parametersCo-Cr single crown |
| Contralateral sound tooth | Active comparator | Other: Periodontal parametersContralateral sound tooth |
Who may qualify
- Ages
- 21 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- good general health
- American Society of Anesthesiologists (ASA) ASA I or ASA II condition; periodontal health
- Angle class I occlusal relationship
- minimum of 10 couples of opponent teeth
- good oral hygiene
Key exclusion criteria (9 listed)
- high caries activity
- presence of periodontal disease on the abutment tooth
- occlusal-cervical height of the abutment tooth < 4 mm
- reduced interocclusal distance or supraerupted opposing teeth
- unfavorable crown-to-root ratio
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 |
|---|---|---|
| Co-Cr single crown | Device | Co-Cr single crown |
| Periodontal parameters | Other | Co-Cr single crown, Contralateral sound tooth |
Primary outcome
Survival percentage
Time frame: 4 years
Kaplan Meier analysis of survival of the prostheses
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 8 Nov 2016.
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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?
A study testing Co-Cr single crown and Periodontal parameters in people with Single Tooth Lost, 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 11 inclusion and 9 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 8 Nov 2016. 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?
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?
Survival percentage (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 8 Nov 2016.