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Completed

NCT Number: NCT04370314

Retrospective Study on Clinical Performance of Screw-retained Implant Crowns

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.

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Key information

Conditions

Dental Implant Failed

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bern

Bern, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental prosthetics

Other

Implant-supported crowns

Primary outcomes

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

    Time frame: 1 year

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

Secondary outcomes

  1. Number of patients with biological complications assessed via clinical examination

    Time frame: 1 year

    A clinical evaluation of the implant crowns will be performed in order to detect any kind of biological complication, namely periimplantitis and perimucositis

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

    Time frame: 1 year

    A radiological evaluation of the implant crowns will be performed to measure and evaluate the bone crestal changes

  3. Number of patients with technical complications

    Time frame: 1 year

    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

  4. Patient satisfaction as assessed by VAS A

    Time frame: 1 year

    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.

  5. Patient satisfaction as assessed by VAS B

    Time frame: 1 year

    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.

  6. Esthetic outcome

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 30, 2020
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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