MedPath

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

Not Applicable
Recruiting
Conditions
Consequences of bruxism: wear and tear of the tooth structure, myopathy of the jaw muscles, CMD (craniomandibular dysorder)
Registration Number
DRKS00031209
Lead Sponsor
Johann Wolfgang Goethe-Universität Frankfurt am Main
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
30
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

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.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Wear of the splint material:<br>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 Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath