Evaluation of the time efficiency and accuracy of analog and digital manufacturing processes for the production of occlusal devices

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00034938

Enrollment

Registered

2024-10-03

Start date

2024-10-14

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruxism, occlusal device

Interventions

Group 1: Subsequent to enrollment, patients will be randomly assigned to one of two fabrication methods (analog or digital) for the production of an occlusal device. For example, if patients are trea

a wash-out phase is not intended. Group 2: At the beginning of the study, the patients are randomly assigned to one fabrication method (analog or digital). In the second part of the study, the other f

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with primary sleep and/or waketime bruxism

Exclusion criteria

Exclusion criteria: - Patients with removable dentures - Smoking, regular use of alcohol, use of drugs

Design outcomes

Primary

Measure	Time frame
- Time efficiency during fabrication: Comparison of the fabrication time between analog and digitally fabricated occlusal splints. The manufacturing steps are divided into dental technology and dental procedures and their duration is recorded. - Accuracy of the occlusal devices: Evaluation of the fit of analog and digitally fabricated occlusal devices by the investigator. - Change in material properties after eight weeks of wear: wear, roughness, color change. The wear of the devices in the occlusal area is quantitatively examined by comparing two scans before and after the wearing period. Changes in roughness before and after the wearing period are recorded using a confocal microscope. Any color changes are documented photographically.	—

Measure

Time frame

- Time efficiency during fabrication: Comparison of the fabrication time between analog and digitally fabricated occlusal splints. The manufacturing steps are divided into dental technology and dental procedures and their duration is recorded. - Accuracy of the occlusal devices: Evaluation of the fit of analog and digitally fabricated occlusal devices by the investigator. - Change in material properties after eight weeks of wear: wear, roughness, color change. The wear of the devices in the occlusal area is quantitatively examined by comparing two scans before and after the wearing period. Changes in roughness before and after the wearing period are recorded using a confocal microscope. Any color changes are documented photographically.

—

Secondary

Measure	Time frame
Evaluation of oral health-related quality of life (OHIP-14), wearing time, cleaning occlusal devices, patient satisfaction.	—

Countries

Germany

Contacts

Public ContactRalf Bürgers

Universitätsmedizin Göttingen, Poliklinik für Zahnärztliche Prothetik

ralf.buergers@med.uni-goettingen.de+49 551 3965654

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 27, 2026