NCT04370314

Brief Summary

Survival and success rates of all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology after at least one year in function. Survival and success rates (clinical, radiologic and esthetic) of all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology after 2 to 10 years in function. Establishment of a database of patients with all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology for future longitudinal retrospective studies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

1.6 years

First QC Date

April 24, 2020

Last Update Submit

May 4, 2020

Conditions

Dental Implant Failed

Outcome Measures

Primary Outcomes (1)

  • Survival and success rates of all-ceramic implant-supported fixed reconstructions

    Number of all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology still in place after at least one year in function.

    1 year

Secondary Outcomes (6)

  • Number of patients with biological complications assessed via clinical examination

    1 year

  • Number of patients with biological complications assessed via periapical x-ray

    1 year

  • Number of patients with technical complications

    1 year

  • Patient satisfaction as assessed by VAS A

    1 year

  • Patient satisfaction as assessed by VAS B

    1 year

  • +1 more secondary outcomes

Study Arms (1)

Zirconia implant-supported crown

EXPERIMENTAL

Full zirconia implant-supported crown

Other: Dental prosthetics

Interventions

Dental prostheticsOTHER

Implant-supported crowns

Zirconia implant-supported crown

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with at least one fixed all-ceramic reconstruction (single implant restoration on BL implant with individualized zirconia abutment directly screwed and directly veneered, three- to five-unit zirconia bridges directly veneered, single tooth crown made of a lithium disilicate glass-ceramic (LS2) blank)
  • Written informed consent

You may not qualify if:

  • Pregnancy at the time of the follow-up examination
  • Mental handicap
  • Patients that could not be contacted/located
  • Patients not interested in participating
  • Patients with the need of antibiotic prophylaxis prior to a clinical examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bern

Bern, Switzerland

Location

Related Publications (1)

  • Fonseca M, Molinero-Mourelle P, Forrer FA, Schnider N, Hicklin SP, Schimmel M, Bragger U. Clinical performance of implant crowns with customized zirconia abutments: A prospective cohort study with a 4.5- to 8.8-year follow-up. Clin Oral Implants Res. 2021 Jul;32(7):853-862. doi: 10.1111/clr.13761. Epub 2021 May 24.

    PMID: 33949004DERIVED

Study Officials

  • Manrique Fonseca, Dr.

    University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 30, 2020

Study Start

September 7, 2017

Primary Completion

April 26, 2019

Study Completion

November 21, 2019

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)