Zirconia Implants for Replacement of a Single Tooth

Sponsor

University of Bern (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04695899

Collaborator

(none)

Enrollment

Location

156

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Partial-edentulism	Device: Dental Implant

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 Design

Study Type:

Observational

Actual Enrollment :

14 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2017

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Feb 28, 2030

Outcome Measures

Primary Outcome Measures

Survival Rate [12 months]
How many implants are still in function

Secondary Outcome Measures

Success Rate [10 years]
How many implants satisfy current biological and technical success criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University od Bern - Klinik für rekonstruktive Zahnmedizin und Gerodontologie	Bern		Switzerland	3010

Sponsors and Collaborators

University of Bern

Investigators

Principal Investigator: SImone FM Janner, PD Dr., University of Bern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Bern

ClinicalTrials.gov Identifier:

NCT04695899

Other Study ID Numbers:

2016-01434

First Posted:

Jan 5, 2021

Last Update Posted:

May 18, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Study Results

No Results Posted as of May 18, 2022