Partial-edentulismNCT04695899
Zirconia Implants for Replacement of a Single Tooth
An observational study of Partial-edentulism, run by University of Bern at 1 site in Switzerland.
Trial summary
First, the surgical insertion of a ceramic (zirconia) dental implant will be performed in a single-tooth gap according to current state-of-the-art protocols. After a 3-months healing phase, a ceramic tooth replacement (a.k.a. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial-edentulism
- What is being tested?
- Dental Implant
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2017to 28 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: General population.
Who may be able to join
- partial edentulism (any FDI position between 17 and 47)
- healed extraction site (type 2, 3 or 4 implant placement) or native bone
- opposing dentition: natural teeth, fixed or removable restoration
- self-referred or on purpose referred patient requiring a metal-free, all-ceramic implant therapy
- age ≥18 years and ≤ 80
- capable of providing written informed consent and compliance to the protocol
- physical status PS1 and PS2 (American Society of Anesthesiologists).
Who cannot join
- inadequate ridge or gap dimensions for the test device (simultaneous bone augmentation allowed)
- lack of primary stability of the implant
- pregnancy or lactation
- inadequate oral hygiene
- untreated periodontitis or gingivitis
- mucosal diseases such as erosive lichen planus
Show all 9Show fewer
- smoking habit with >5 cig/d
- severe bruxism or clenching habits
- uncontrolled diabetes or conditions resulting in or requiring immunosuppression, radiation, chemotherapy, frequent use of antibiotics or antiresorptive medication such as bisphosphonates
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Bern - Klinik für rekonstruktive Zahnmedizin und Gerodontologie
Bern, 3010
About this study
Official title: Observational Study Evaluating Zirconia Dental Implants and Screw Retained Implant Crowns for Metal-free Single Tooth Replacement
First, the surgical insertion of a ceramic (zirconia) dental implant will be performed in a single-tooth gap according to current state-of-the-art protocols. After a 3-months healing phase, a ceramic tooth replacement (a.k.a. implant crown) will be screw-retained on the implant and will be ready for full chewing, aesthetic and speech function.
Read the detailed description
Surgery Implant placement will be performed according to a standardized, well-documented surgical protocol considered internationally as state-of-the art therapy for titanium implants since decades (Buser \& von Arx 2000, Buser et al. 2004). In summary, an osteotomy will be performed in the edentulous bone under local anaesthesia and after the elevation of a full-thickness mucoperiosteal flap. The screw-shaped implant will then be inserted into the osteotomy. Particular emphasis will be set on risk minimization for adjacent anatomical structures (e.g. nerves, adjacent teeth), on sufficient primary implant stability, on circular embedding in > 1 mm thick bone walls and on correct three-dimensional implant positioning. In cases with insufficient bone volume, guided bone regeneration (GBR) will be performed using autogenous bone chips from the adjacent area, well-documented bovine bone mineral and resorbable porcine collagen membranes. The flaps will then be sutured around the implant healing cap (non-submerged healing). Primary flap closure will be preferred in cases with GBR (submerged healing). 12 ± 2 weeks after placement, submerged implants will be uncovered under local anaesthesia, then the osseointegration of the implants will be verified clinically and radiographically, and impressions will be taken.
Restoration Restoration in group A (tooth replacement in FDI positions 14 - 24): fixed implant-supported provisional for 3 months, then final restoration with all-ceramic screw-retained single implant-supported crown (abutment made of zirconium dioxide and crown finalized with hand-build up ceramic veneering material) Restoration in group B (tooth replacement in all other positions): all-ceramic screw-retained single implant-supported crown (abutment made of zirconium dioxide and monolithic lithium disilicate ceramic crown.
- Conditions
- Partial-edentulism
- Being tested
- Dental Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental ImplantDevice
See Section "Procedures".
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate
How many implants are still in function
Measured: 12 months
Secondary outcomes (1)
Success Rate
How many implants satisfy current biological and technical success criteria
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Mar 2017
- Primary completion28 Feb 2025
- Study completion28 Feb 2030 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SImone FM Janner, PD Dr., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695899
- Sponsor's protocol ID
- 2016-01434
- Other IDs
- 2016
- Status last verified
- Apr 2026
- First submitted
- 4 Jan 2021
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Evaluating Zirconia Dental Implants and Screw Retained Implant Crowns for Metal-free Single Tooth Replacement
- ClinicalTrials.gov ID
- NCT04695899
- Acronym / sponsor ID
- 2016-01434
- Conditions
- Partial-edentulism
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 5 Jan 2021 (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.
First, the surgical insertion of a ceramic (zirconia) dental implant will be performed in a single-tooth gap according to current state-of-the-art protocols. After a 3-months healing phase, a ceramic tooth replacement (a.k.a. implant crown) will be screw-retained on the implant and will be ready for full chewing, aesthetic and speech function.
Detailed description
Surgery Implant placement will be performed according to a standardized, well-documented surgical protocol considered internationally as state-of-the art therapy for titanium implants since decades (Buser \& von Arx 2000, Buser et al. 2004). In summary, an osteotomy will be performed in the edentulous bone under local anaesthesia and after the elevation of a full-thickness mucoperiosteal flap. The screw-shaped implant will then be inserted into the osteotomy. Particular emphasis will be set on risk minimization for adjacent anatomical structures (e.g. nerves, adjacent teeth), on sufficient primary implant stability, on circular embedding in > 1 mm thick bone walls and on correct three-dimensional implant positioning. In cases with insufficient bone volume, guided bone regeneration (GBR) will be performed using autogenous bone chips from the adjacent area, well-documented bovine bone mineral and resorbable porcine collagen membranes. The flaps will then be sutured around the implant healing cap (non-submerged healing). Primary flap closure will be preferred in cases with GBR (submerged healing). 12 ± 2 weeks after placement, submerged implants will be uncovered under local anaesthesia, then the osseointegration of the implants will be verified clinically and radiographically, and impressions will be taken.
Restoration Restoration in group A (tooth replacement in FDI positions 14 - 24): fixed implant-supported provisional for 3 months, then final restoration with all-ceramic screw-retained single implant-supported crown (abutment made of zirconium dioxide and crown finalized with hand-build up ceramic veneering material) Restoration in group B (tooth replacement in all other positions): all-ceramic screw-retained single implant-supported crown (abutment made of zirconium dioxide and monolithic lithium disilicate ceramic crown.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- General population.
Key inclusion criteria (7 listed)
- partial edentulism (any FDI position between 17 and 47)
- healed extraction site (type 2, 3 or 4 implant placement) or native bone
- opposing dentition: natural teeth, fixed or removable restoration
- self-referred or on purpose referred patient requiring a metal-free, all-ceramic implant therapy
- age ≥18 years and ≤ 80
Key exclusion criteria (9 listed)
- inadequate ridge or gap dimensions for the test device (simultaneous bone augmentation allowed)
- lack of primary stability of the implant
- pregnancy or lactation
- inadequate oral hygiene
- untreated periodontitis or gingivitis
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 ImplantSee Section "Procedures". | Device | – |
Primary outcome
Survival Rate
Time frame: 12 months
How many implants are still in function
1 secondary outcome
Success Rate
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Partial-edentulism
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Not yet recruiting
Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
Partial Edentulism Class 1 or Class 2
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Active, not recruiting
Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
Partial Edentulism Class 3, Removable Partial Denture
Active, not recruitingObservational study
Survival of Implant-Supported All-Ceramic Prostheses
Partial Edentulism, Disorder of Prostheses and Implants
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.
SImone FM Janner, PD 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?
An observational study of Partial-edentulism, 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 7 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 Rate (time frame: 12 months). 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 17 Apr 2026.