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NCT Number: NCT04695899

Zirconia Implants for Replacement of a Single Tooth

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Bern - Klinik für rekonstruktive Zahnmedizin und Gerodontologie

Bern, 3010, Switzerland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(site level):

  • 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

Exclusion criteria

(site level):

  • inadequate ridge or gap dimensions for the test device (simultaneous bone augmentation allowed)
  • lack of primary stability of the implant

Inclusion criteria

(patient level):

  • 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).

Exclusion criteria

(patient level):

  • pregnancy or lactation
  • inadequate oral hygiene
  • untreated periodontitis or gingivitis
  • mucosal diseases such as erosive lichen planus
  • 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

Treatment and study plan

dental implant

Device

See Section "Procedures".

Primary outcomes

  1. Survival Rate

    Time frame: 12 months

    How many implants are still in function

Secondary outcomes

  1. Success Rate

    Time frame: 10 years

    How many implants satisfy current biological and technical success criteria

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2025
Study completion
2030
First posted
Jan 5, 2021
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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