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Clinical prospective study on the probation of additively manufactured bite splints in direct comparison to splints made of milled PMMA

Clinical prospective study on the probation of additively manufactured bite splints in direct comparison to splints made of milled PMMA - Clinical probation of 3D printed bite splints

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00031209
Enrollment
30
Registered
2023-05-04
Start date
2023-09-13
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Consequences of bruxism: wear and tear of the tooth structure, myopathy of the jaw muscles, CMD (craniomandibular dysorder)

Interventions

Group 1: Additively manufactured bite splints and milled PMMA bite splints as a split mouth design.

Sponsors

Johann Wolfgang Goethe-Universität Frankfurt am Main
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients over 18 years of age, fully dentate or fixed prosthetic upper and lower jaw, indication for the preparation of a bite splint as a nightguard, presence of eccentric bruxism or other nocturnal parafunctions of the jaw with movement pattern - evidence by BruxCheck, no arthropathy of the temporomandibular joints requiring treatment, no planned need for dental treatment during the examination period - excluding teeth cleaning, signed consent and data protection declaration on a voluntary basis for participation in the study

Exclusion criteria

Exclusion criteria: Patients under 18 years of age, edentulous patients or patients treated with removable dentures, no presence of bruxism or other nocturnal parafunctions of the jaw, arthropathy of the temporomandibular joints requiring treatment, dental treatment required during the study period - with the exception of tooth cleaning, lack of consent and data protection declaration, participation in the planning and implementation of the study, Presence of alcohol or drug abuse, Uncontrolled pathological processes in the oral cavity, Mental or psychosomatic illness that would affect participation in the study and compliance with the study protocol.

Design outcomes

Primary

MeasureTime frame
Wear of the splint material: The wear is recorded by means of a surface scan after the test wear and after 3 and 6 months of wearing. The surfaces are scanned with high-precision scanners (GOM Atos 135, GOM Metrology, Braunschweig). Wear is determined by superimposing the scans and using the GOM Inspect analysis software.

Secondary

MeasureTime frame
1. Resistance to discoloration: The resistance to discoloration is assessed with overhead photography under standardized conditions after the test wear and after 3 and 6 months of wear and by a blinded rater in a direct comparison of the two materials. Photographing is carried out under standardized conditions, the camera body EOS 90D from Canon, the flash Macro Flash 18 from Nissin and the macro lens 105mm F2.8 EX DG Macro OS from Sigma. The standardized settings ??are aperture F20, exposure time 1/200, sensitivity ISO 200, flash ETTL. The color values ??are then calibrated and objectified. As a uniform background, the same black background is used for every shot. The lighting conditions and white balance are uniformly calibrated using a gray card. 2. Wearing comfort: The wearing comfort is evaluated in a direct comparison of the two materials using questionnaires after 3 and 6 months of wearing. In addition to the standardized questionnaires PHQ-9, HADS-D, stress load according to Ahlers/Jakstat, Bruxism Screening Index (BSI) and OHIP, questionnaires on wearing comfort and subjective evaluation of the splint materials are used.

Countries

Germany

Contacts

Public ContactSilvia Brandt

Johann Wolfgang Goethe-Universität Frankfurt am Main

brandt@med.uni-frankfurt.de+496963015640

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026