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
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
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- 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.
- 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