Zirconia Implants for Replacement of a Single Tooth

NCT04695899 | Active Not Recruiting

• 1 other identifier: 2016-01434
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Partial-edentulism

Outcome Measures

Primary Outcomes (1)

• Survival Rate

  How many implants are still in function

  12 months

Secondary Outcomes (1)

• Success Rate

  10 years

Interventions

Dental Implant DEVICE

See Section "Procedures".

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General population.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University of Bern - Klinik für rekonstruktive Zahnmedizin und Gerodontologie

Bern, 3010, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Crevicular/sulcus fluid.

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• SImone FM Janner, PD Dr.

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 5, 2021
• Study Start: March 1, 2017
• Primary Completion: February 28, 2025
• Study Completion (Estimated): February 28, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)