Retrospective Study on Clinical Performance of Screw-retained Implant Crowns

Dental Implant Failed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04370314
• Other study ID #: 020/13
• Status: Completed
• Phase: N/A
• Start date: September 7, 2017
• Est. completion date: November 21, 2019

Study information

• Verified date: May 2020
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 21, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant Failed

Intervention

Other:
• Dental prosthetics
Implant-supported crowns

Locations

Country	Name	City	State
Switzerland	University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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