Retrospective Study on Clinical Performance of Screw-retained Implant Crowns

Clinical Performance of One-piece Screw-retained Implant Crowns Base on CAD/CAM Hand-veneered Zirconium Dioxide Customized Abutments With a 6 Years and 7 Months Mean Follow-up

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.

Study Overview

• Status: Completed
• Conditions: Dental Implant Failed
• Intervention / Treatment: Other: Dental prosthetics

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland
    • University of Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zirconia implant-supported crown; Full zirconia implant-supported crown	Other: Dental prosthetics; Implant-supported crowns

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with biological complications assessed via clinical examination	A clinical evaluation of the implant crowns will be performed in order to detect any kind of biological complication, namely periimplantitis and perimucositis	1 year
Number of patients with biological complications assessed via periapical x-ray	A radiological evaluation of the implant crowns will be performed to measure and evaluate the bone crestal changes	1 year
Number of patients with technical complications	A clinical evaluation of the implant crowns will be performed in order to detect any kind of complication, namely chipping, screw loosening or abutment fracture	1 year
Patient satisfaction as assessed by VAS A	Patients assess by patient questionnaire their implant reconstructions, in terms of function by means of a Visual Analog Scale (VAS A), where the parameter will be scored from 1 to 10.	1 year
Patient satisfaction as assessed by VAS B	Patients assess by patient questionnaire their implant reconstructions, in terms of esthetics by means of a Visual Analog Scale (VAS B), where the parameter will be scored from 1 to 10.	1 year
Esthetic outcome	The esthetic examination included the Pink and White Esthetic Score Assessment (PES/WES) according to Belser et al. 2009 & Furhäuser et al. 2005 on a scale from 0-10 whereas 10 means an optimal outcome.	1 year

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Principal Investigator: Manrique Fonseca, Dr., University of Bern

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2017
• Primary Completion (Actual): April 26, 2019
• Study Completion (Actual): November 21, 2019

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 020/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No