Prospective clinical pilot trial to establish a clinical standard for accuracy verification of two different impression systems, digital and conventional.

Not Applicable

Recruiting

• Conditions: Existing need for a fixed prosthetic restoration of 2 or more abutment teeth or implants. This includes both single crowns and a bridge restoration.

• Registration Number: DRKS00025724
• Lead Sponsor: ehr-, und Forschungsgebiet Computergestützte Zahnmedizin Klinik für Zahnärztliche Prothetik und Biomaterialien des Universitätsklinikums Aachen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. patients who require a fixed prosthetic restoration of 2 or more abutment teeth or implants. This includes both single crowns and a bridge restoration.
2. healthy periodontium and non-inflamed periapical tissue or root canal-treated teeth with a good endodontic prognosis.
3. osseointegrated implants and non-inflamed peri-implant tissue.
4. patients of legal age who are mentally and physically able to understand the significance and scope of the study and to comply with the study personnel.
5. good health status according to the ASA Physical Status Classification one or two (ASA 2019).
6. have signed a written informed consent form prior to participation in the study.

Exclusion Criteria

1. teeth not worthy of preservation.
2. implants with peri-implant signs of inflammation.
3. women with known pregnancy and/or breastfeeding women.
4. study participation may, at the discretion of the investigator, pose an unacceptable risk due to pre-existing or concomitant disease, or due to the patient's general underlying condition.
5. expected lack of compliance.
6. alcohol or drug abuse
7. the patient is institutionalised due to an official or court order.
8. persons in a relationship of dependency or employment with the sponsor or investigator.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the planned study is to establish a clinical standard for the fabrication of fixed prosthetic restorations on two and more abutments (natural teeth and implant superstructures) using the digital workflow. The aim is to compare and prove that these restorations fabricated using digital workflow are equivalent or superior to conventionally fabricated restorations in terms of fitting accuracy. The restorations are evaluated using the internationally recognised FDI criteria and, in the case of natural teeth, fit checker samples. In addition, the time required for clinical adjustment of the internal, marginal, proximal and occlusal adjustments are recorded. <br>Additionally patients are asked about all steps applied in terms of comfort. Patient satisfaction is assessed using VAS (Visual Analogue Scale), PROMS (Patient reported outcomes measurement Information System) and PREMS (Patient reported experience measures).

Secondary Outcome Measures

Name	Time	Method
- Patient safety: Reduction of patient/practice contact times, as there is the potential to fabricate the restoration(s) [bridge, single crowns] in one session when using the digital workflow.<br>- Economic factors for practice and patient: Time saving, as the use of digital workflow offers the potential to fabricate the restoration(s) [bridge, single crowns] in one session.<br>- Material savings and reduction of personnel, avoidance of analogue laboratory steps, such as analogue model fabrication or complete avoidance of model fabrication.<br>- Avoidance of transport routes through in house production.<br>- Establishment in student education