deltatrials
Active Not Recruiting OBSERVATIONAL NCT04695899

Zirconia Implants for Replacement of a Single Tooth

Observational Study Evaluating Zirconia Dental Implants and Screw Retained Implant Crowns for Metal-free Single Tooth Replacement

Sponsor: University of Bern

Interventions Dental Implant
Updated 8 times since 2021 Last updated: Apr 14, 2026 Started: Mar 1, 2017 Primary completion: Feb 28, 2025 Completion: Feb 28, 2030
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04695899, this observational or N/A phase trial focuses on Partial-edentulism and remains ongoing. Sponsored by University of Bern, it has been updated 8 times since 2017, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

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...

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.

Status Flow

~Feb 2021 – ~Dec 2021 · 10 months · monthly snapshotActive Not Recruiting~Dec 2021 – ~Jun 2022 · 6 months · monthly snapshotActive Not Recruiting~Jun 2022 – ~Jan 2024 · 19 months · monthly snapshotActive Not Recruiting~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshotActive Not Recruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotActive Not Recruiting~Sep 2024 – ~May 2025 · 8 months · monthly snapshotActive Not Recruiting~May 2025 – ~Apr 2026 · 12 months · monthly snapshotActive Not RecruitingApr 18, 2026 – present · 2 months · daily APIActive Not Recruiting

Change History

8 versions recorded
  1. Apr 18, 2026 — Present [daily]

    Active Not Recruiting

  2. May 2025 — Apr 2026 [monthly]

    Active Not Recruiting

  3. Sep 2024 — May 2025 [monthly]

    Active Not Recruiting

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting

  5. Jan 2024 — Jul 2024 [monthly]

    Active Not Recruiting

Show 3 earlier versions
  1. Jun 2022 — Jan 2024 [monthly]

    Active Not Recruiting

  2. Dec 2021 — Jun 2022 [monthly]

    Active Not Recruiting

  3. Feb 2021 — Dec 2021 [monthly]

    Active Not Recruiting

    First recorded

Mar 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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. implant crown) will be screw-retained on the implant and will be ready for full chewing, aesthetic and speech function.

Contact Information

Sponsor contact:
  • University of Bern
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations