Implant-supported Single CrownsNCT01644630
To Compare Cemented Versus Screw-retained Implant-supported Single Crowns With Customized Zirconia Abutments
A study testing Cemented crowns and Screw-retained crowns in people with Implant-supported Single Crowns, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim of this study is to test whether or not the use of screw-retained implant crowns on customized zirconia abutments results in biological, technical and esthetic outcomes similar to those obtained with cemented all-ceramic crowns on customized zirconia abutments, both made with a computer-aided design and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Implant-supported Single Crowns
- What is being tested?
- Cemented crowns and Screw-retained crowns
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Jul 2012to 11 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single-tooth Straumann Bone Level in the anterior maxilla or mandible
- At least one adjacent natural tooth present
- Implant position enabling both screw-retained and cemented crown
- Informed consent signed
Who cannot join
- Smoking more than 15 cigarettes a day
- Poor oral hygiene (Plaque index over 30%)
- Pregnancy at the date of inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Clinical Trial Comparing Cemented Versus Screw-retained Implant-supported Single Crowns With Customized Zirconia Abutments
The aim of this study is to test whether or not the use of screw-retained implant crowns on customized zirconia abutments results in biological, technical and esthetic outcomes similar to those obtained with cemented all-ceramic crowns on customized zirconia abutments, both made with a computer-aided design and manufacturing procedure (CAD/CAM).
The null-hypotheses is that marginal bone level change is equal at screw-retained and cemented crowns
- Conditions
- Implant-supported Single Crowns
- Being tested
- Cemented crowns, Screw-retained crowns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cemented crownsProcedure or surgery
The final lithium disilicate crowns will be cemented with an adhesive cement after tightening the abutments with the torque indicated by the manufacturer and closing the screw access hole with white guttapercha. The abutment will be cleaned with ethanol. A retraction cord will be placed for cementation if indicated. The crown will be etched with hydrofluoric acid and subsequently silanized. A sufficient amount of cement will be filled in the crown without creating major excesses. When the crown is seated correctly, the cement will be light-cured for a few seconds to facilitate the removal of the now hard excess cement.
- Excess cement will be meticulously removed with a carbon scaler. The removal of all excess cement will be checked with an X-ray and by visual and tactile inspection.
Screw-retained crownsProcedure or surgery
The screw-retained crowns will be inserted and tightened with the torque indicated by the manufacturer. The screw access hole will to be closed with white guttapercha and a composite filling (Filtek, 3M ESPE).
| Study group | Role | What they receive |
|---|---|---|
| Cemented single crowns | Active comparator | Cemented single crown: zirconia abutment (Straumann Cares abutment) with an all-ceramic lithium disilicate crown Receives: Procedure: Cemented crowns |
| Screw-retained single crown | Active comparator | Screw-retained single crown: zirconia abutment (Straumann Cares abutment), directly veneered with veneering ceramic Receives: Procedure: Screw-retained crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone level
The bone level represents an indicator of the osseointegration and biological success of the implant.
Measured: 5 years
Secondary outcomes (4)
Biological, technical and esthetic outcome
Radiographic bone level after 1 and 3 years
Measured: up to 5 years
Biological, technical and esthetic outcome
implant survival after 1, 3 and 5 years
Measured: up to 5 years
Biological, technical and esthetic outcome
rate of biological complications after 1, 3 and 5 years
Measured: up to 5 years
Biological, technical and esthetic outcome
rate of technical complications after 1, 3 and 5 years
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study start27 Jul 2012
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant-supported Single CrownsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Thoma, Prof. Dr., Principal investigator, Clinic of Reconstructive Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644630
- Sponsor's protocol ID
- 2012-0147
- Status last verified
- Nov 2020
- First submitted
- 9 Jul 2012
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial Comparing Cemented Versus Screw-retained Implant-supported Single Crowns With Customized Zirconia Abutments
- ClinicalTrials.gov ID
- NCT01644630
- Acronym / sponsor ID
- 2012-0147
- Conditions
- Implant-supported Single Crowns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 27 Jul 2012 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 19 Jul 2012 (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.
The aim of this study is to test whether or not the use of screw-retained implant crowns on customized zirconia abutments results in biological, technical and esthetic outcomes similar to those obtained with cemented all-ceramic crowns on customized zirconia abutments, both made with a computer-aided design and manufacturing procedure (CAD/CAM).
The null-hypotheses is that marginal bone level change is equal at screw-retained and cemented crowns
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cemented single crowns | Active comparator | Procedure: Cemented crownsCemented single crown: zirconia abutment (Straumann Cares abutment) with an all-ceramic lithium disilicate crown |
| Screw-retained single crown | Active comparator | Procedure: Screw-retained crownsScrew-retained single crown: zirconia abutment (Straumann Cares abutment), directly veneered with veneering ceramic |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Single-tooth Straumann Bone Level in the anterior maxilla or mandible
- At least one adjacent natural tooth present
- Implant position enabling both screw-retained and cemented crown
- Informed consent signed
Key exclusion criteria (3 listed)
- Smoking more than 15 cigarettes a day
- Poor oral hygiene (Plaque index over 30%)
- Pregnancy at the date of inclusion
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 |
|---|---|---|
| Cemented crownsThe final lithium disilicate crowns will be cemented with an adhesive cement after tightening the abutments with the torque indicated by the manufacturer and closing the screw access hole with white guttapercha. The abutment will be cleaned with ethanol. A retraction cord will be placed for cementation if indicated. The crown will be etched with hydrofluoric acid and subsequently silanized. A sufficient amount of cement will be filled in the crown without creating major excesses. When the crown is seated correctly, the cement will be light-cured for a few seconds to facilitate the removal of the now hard excess cement. - Excess cement will be meticulously removed with a carbon scaler. The removal of all excess cement will be checked with an X-ray and by visual and tactile inspection. | Procedure or surgery | Cemented single crowns |
| Screw-retained crownsThe screw-retained crowns will be inserted and tightened with the torque indicated by the manufacturer. The screw access hole will to be closed with white guttapercha and a composite filling (Filtek, 3M ESPE). | Procedure or surgery | Screw-retained single crown |
Primary outcome
Marginal bone level
Time frame: 5 years
The bone level represents an indicator of the osseointegration and biological success of the implant.
4 secondary outcomes
Biological, technical and esthetic outcome
Time frame: up to 5 years
Biological, technical and esthetic outcome
Time frame: up to 5 years
Biological, technical and esthetic outcome
Time frame: up to 5 years
Biological, technical and esthetic outcome
Time frame: up to 5 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 6 Nov 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.
Daniel Thoma, Prof. Dr. principal investigator
Clinic of Reconstructive Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cemented crowns and Screw-retained crowns in people with Implant-supported Single Crowns, run by University of Zurich 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 4 inclusion and 3 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 Nov 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?
Marginal bone level (time frame: 5 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 6 Nov 2020.