Clinical Performance of CAD/CAM Occlusal Splints Fabricated With or Without Wax Bite Registration in Healthy Adults
Clinical Performance of CAD/CAM Occlusal Splints Fabricated With or Without Wax Bite Registration: A Randomized Crossover Clinical Trial
Occlusal splints are commonly used to manage sleep bruxism, temporomandibular disorders, and tooth wear. Traditionally, a wax bite registration is used during the fabrication of CAD/CAM occlusal splints to determine the vertical dimension and occlusal relationship. New digital techniques allow the splint to be designed without a wax bite registration by virtually increasing the vertical dimension based on maximal occlusion.
This randomized crossover study compares these two fabrication workflows in healthy volunteers. Participants will wear both splints in random order. The study will evaluate patient-reported comfort and clinical performance, including occlusal contacts, force distribution, splint stability, and the occlusal adjustments required at insertion.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Occlusal splints are widely used in the management of sleep bruxism, temporomandibular disorders, and tooth wear. The increasing implementation of CAD/CAM technology has improved the efficiency and reproducibility of occlusal splint fabrication. Conventionally, the vertical dimension and occlusal relationship are determined using a wax bite registration. Recent developments in digital dentistry now allow the vertical dimension to be increased virtually based on the patient's maximal intercuspation, eliminating the need for an additional wax bite registration.
Although both fabrication workflows are currently used in clinical practice, there is limited clinical evidence comparing their performance. It remains unclear whether omitting the conventional wax bite registration affects the initial clinical performance of CAD/CAM occlusal splints at insertion, before any occlusal adjustments are performed. Potential differences may exist in patient comfort, splint stability, occlusal contacts, force distribution, and the number of occlusal adjustments required. In addition, little is known about differences in patient-reported outcomes, including comfort, perceived occlusion, stability, and overall satisfaction during the period of splint use.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Sabine Mechelse, MSc
- Telefonnummer: 0031648136263
- E-mail: sabine.mechelse@radboudumc.nl
Undersøgelse Kontakt Backup
- Navn: Stanimira Kalaykova-Sparreboom, dr.
- E-mail: stanimira.kalaykova@radboudumc.nl
Studiesteder
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Gelderland
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Nijmegen, Gelderland, Holland, 6525EX
- Radboudumc
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Kontakt:
- Sabine Mechelse, MSc
- Telefonnummer: 0031648136263
- E-mail: sabine.mechelse@radboudumc.nl
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion criteria:
- Subjects aged 18-45 years
- Subjects being healthy (ASA I-III)
- Subjects with healthy, complete dentitions (except for congenitally missing teeth (agenesis), extractions of wisdom teeth, or tooth extractions for the purpose of orthodontic treatment in the past)
- Subjects willing and able to participate in the study
- Subjects willing to provide written informed consent for their participation in the study
Exclusion Criteria:
- Subjects presenting with active dental disease, extensive restorations affecting the occlusion, or other oral conditions that may interfere with the assessment of the occlusal splints.
- Subjects with a history of autoimmune disorder Subjects with known allergies to acrylic materials
- Subjects with severe allergies manifested by a history of anaphylaxis or those with severe, chronic allergies (e.g., asthma) and subjects with an active infection of any kind at the time of enrollment
- Subjects who are pregnant or lactating
- Subjects enrolled in another investigational clinical trial
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Participant-reported comfort
Tidsramme: From enrollment to the end of treatment at 7 weeks
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Self reported wear comfort by filling in a questionnaire.
This scale measures the comfort of the occlusal splint (0-10), where "very uncomfortable" represents the worst experience (lowest score) and "Very comfortable" represents the best experience (highest score).
Minimum Value: Very uncomfortable, Maximum Value: Very comfortable.
Higher Scores Mean: Better comfort (more comfort)
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From enrollment to the end of treatment at 7 weeks
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Sabine Mechelse, MSc, Radboud University Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R0147841A
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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