Zirconia Implants for Replacement of a Single Tooth

Active, not recruiting

• Conditions: Partial-edentulism

• Registration Number: NCT04695899
• Lead Sponsor: University of Bern

Brief 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.

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 Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-05
• Primary Completion: 2025-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Study Completion: 2030-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival Rate	12 months	How many implants are still in function

Secondary Outcome Measures

Name	Time	Method
Success Rate	10 years	How many implants satisfy current biological and technical success criteria

Trial Locations

Locations (1)

University of Bern - Klinik für rekonstruktive Zahnmedizin und Gerodontologie; 🇨🇭 Bern, Switzerland