Dental Implant FailedNCT04370314
Retrospective Study on Clinical Performance of Screw-retained Implant Crowns
A study testing Dental prosthetics in people with Dental Implant Failed, run by University of Bern at 1 site in Switzerland.
Trial summary
Survival and success rates of all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology after at least one year in function. Survival and success rates (clinical, radiologic and esthetic) of all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology after 2 to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed
- What is being tested?
- Dental prosthetics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Sep 2017to 21 Nov 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with at least one fixed all-ceramic reconstruction (single implant restoration on BL implant with individualized zirconia abutment directly screwed and directly veneered, three- to five-unit zirconia bridges directly veneered, single tooth crown made of a lithium disilicate glass-ceramic (LS2) blank)
- Written informed consent
Who cannot join
- Pregnancy at the time of the follow-up examination
- Mental handicap
- Patients that could not be contacted/located
- Patients not interested in participating
- Patients with the need of antibiotic prophylaxis prior to a clinical examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of One-piece Screw-retained Implant Crowns Base on CAD/CAM Hand-veneered Zirconium Dioxide Customized Abutments With a 6 Years and 7 Months Mean Follow-up
Survival and success rates of all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology after at least one year in function.
Survival and success rates (clinical, radiologic and esthetic) of all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology after 2 to 10 years in function.
Establishment of a database of patients with all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology for future longitudinal retrospective studies.
- Conditions
- Dental Implant Failed
- Being tested
- Dental prosthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental prostheticsOther
Implant-supported crowns
| Study group | Role | What they receive |
|---|---|---|
| Zirconia implant-supported crown | Experimental | Full zirconia implant-supported crown Receives: Other: Dental prosthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival and success rates of all-ceramic implant-supported fixed reconstructions
Number of all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology still in place after at least one year in function.
Measured: 1 year
Secondary outcomes (6)
Number of patients with biological complications assessed via clinical examination
A clinical evaluation of the implant crowns will be performed in order to detect any kind of biological complication, namely periimplantitis and perimucositis
Measured: 1 year
Number of patients with biological complications assessed via periapical x-ray
A radiological evaluation of the implant crowns will be performed to measure and evaluate the bone crestal changes
Measured: 1 year
Number of patients with technical complications
A clinical evaluation of the implant crowns will be performed in order to detect any kind of complication, namely chipping, screw loosening or abutment fracture
Measured: 1 year
Patient satisfaction as assessed by VAS A
Patients assess by patient questionnaire their implant reconstructions, in terms of function by means of a Visual Analog Scale (VAS A), where the parameter will be scored from 1 to 10.
Measured: 1 year
Patient satisfaction as assessed by VAS B
Patients assess by patient questionnaire their implant reconstructions, in terms of esthetics by means of a Visual Analog Scale (VAS B), where the parameter will be scored from 1 to 10.
Measured: 1 year
Esthetic outcome
The esthetic examination included the Pink and White Esthetic Score Assessment (PES/WES) according to Belser et al. 2009 \& Furhäuser et al. 2005 on a scale from 0-10 whereas 10 means an optimal outcome.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start7 Sep 2017
- Primary completion26 Apr 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- More trials run by University of BernThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manrique Fonseca, Dr., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370314
- Sponsor's protocol ID
- 020/13
- Status last verified
- May 2020
- First submitted
- 24 Apr 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fonseca M, Molinero-Mourelle P, Forrer FA, Schnider N, Hicklin SP, Schimmel M, Bragger U. Clinical performance of implant crowns with customized zirconia abutments: A prospective cohort study with a 4.5- to 8.8-year follow-up. Clin Oral Implants Res. 2021 Jul;32(7):853-862. doi: 10.1111/clr.13761. Epub 2021 May 24.
PubMed 33949004
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of One-piece Screw-retained Implant Crowns Base on CAD/CAM Hand-veneered Zirconium Dioxide Customized Abutments With a 6 Years and 7 Months Mean Follow-up
- ClinicalTrials.gov ID
- NCT04370314
- Acronym / sponsor ID
- 020/13
- Conditions
- Dental Implant Failed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 30 Apr 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.
Survival and success rates of all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology after at least one year in function.
Survival and success rates (clinical, radiologic and esthetic) of all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology after 2 to 10 years in function.
Establishment of a database of patients with all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology for future longitudinal retrospective studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zirconia implant-supported crown | Experimental | Other: Dental prostheticsFull zirconia implant-supported crown |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with at least one fixed all-ceramic reconstruction (single implant restoration on BL implant with individualized zirconia abutment directly screwed and directly veneered, three- to five-unit zirconia bridges directly veneered, single tooth crown made of a lithium disilicate glass-ceramic (LS2) blank)
- Written informed consent
Key exclusion criteria (5 listed)
- Pregnancy at the time of the follow-up examination
- Mental handicap
- Patients that could not be contacted/located
- Patients not interested in participating
- Patients with the need of antibiotic prophylaxis prior to a clinical examination
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 |
|---|---|---|
| Dental prostheticsImplant-supported crowns | Other | Zirconia implant-supported crown |
Primary outcome
Survival and success rates of all-ceramic implant-supported fixed reconstructions
Time frame: 1 year
Number of all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology still in place after at least one year in function.
6 secondary outcomes
Number of patients with biological complications assessed via clinical examination
Time frame: 1 year
Number of patients with biological complications assessed via periapical x-ray
Time frame: 1 year
Number of patients with technical complications
Time frame: 1 year
Patient satisfaction as assessed by VAS A
Time frame: 1 year
Patient satisfaction as assessed by VAS B
Time frame: 1 year
Esthetic outcome
Time frame: 1 year
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 6 May 2020.
- Derived from this study: PubMed 33949004Fonseca M, Molinero-Mourelle P, Forrer FA, Schnider N, Hicklin SP, Schimmel M, Bragger U. Clinical performance of implant crowns with customized zirconia abutments: A prospective cohort study with a 4.5- to 8.8-year follow-up. Clin Oral Implants Res. 2021 Jul;32(7):853-862. doi: 10.1111/clr.13761. Epub 2021 May 24.
- Individual participant dataSharing planned: No
Related trials for Dental Implant Failed
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
Recruiting
Clinical Performance of Dual-cantilevered Single-implant Bridge
Dental Implant Failed
Active, not recruiting
Simultaneous Implant Placement With Vertical and Horizontal Bone Augmentation
Alveolar Bone Loss, Dental Implant Failed
Enrolling by invitationObservational study
Short Implants Produced by Additive Manufacturing in the Posterior Jaws: 3 Years of Follow-up
Periodontal Diseases, Dental Implant Failed
Recruiting
Effect of Systemic Vitamin D on Dental Implant Osseointegration
Dental Implant, Dental Implant Failed
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.
Manrique Fonseca, Dr. principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental prosthetics in people with Dental Implant Failed, run by University of Bern at 1 site in Switzerland.
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 2 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 6 May 2020. 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 Switzerland. 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?
Survival and success rates of all-ceramic implant-supported fixed reconstructions (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04370314, which also lists 1 linked publication.
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 6 May 2020.