Clinical trial NCT06518447: Conventional vs Digital CAD/CAM Splints for Bruxism
Official title: Randomized Cross-clinical Trial Comparing Precision of Conventional Stabilization Splints (Michigan Type) Versus CAD/CAM Splints With Fully Digital Flow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bruxism
Keywords: occlusal splints
computer-aided design
bruxism
Lead sponsor: Pontificia Universidade Católica do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial with a crossover design, which intends to enroll 20 adult patients aged between 20 and 55 years with confirmed or probable sleep bruxism. Participants will be randomized to receive either a conventional stabilization splint or a CAD/CAM splint. Each patient will use one type of splint for 30 days, followed by a 15-day wash-out period, after which they will switch to the other type of splint. The study aims to compare the quality, precision, and comfort of the two types of occlusal splints. Outcomes will include manufacturing time, amount of in-mouth adjustments, adaptation, occlusal contacts, and participant satisfaction.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged between 20 and 55 years.
* Probable or confirmed diagnosis of sleep bruxism.
* No previous treatment with occlusal splints.
* Absence of periodontal diseases and/or dental fractures.
* Patients must have a minimum of 28 teeth.

Exclusion Criteria:

* Patients with systemic diseases affecting the temporomandibular joint, such as rheumatoid arthritis, osteoarthritis, and osteoporosis.
* Chronic users of medications that may interfere with the study results, including analgesics, anti-inflammatory drugs, anxiolytics, antidepressants, and anticonvulsants.
* Patients with a history of temporomandibular joint surgery.
* Pregnant or breastfeeding women.
* Patients with severe dental misalignment or malocclusion that would affect splint fitting and evaluation.

Primary outcomes:
measure: Number of occlusal contacts
timeFrame: Immediately after the initial installation
Secondary outcomes:
measure: Time Required for Splint Adjustment
timeFrame: Immediately after the initial installation and adjustment
measure: Participant satisfaction after installation
timeFrame: Immediately after the initial installation and adjustment
measure: Participant satisfaction after 30 days
timeFrame: After 30 days of use
measure: Splint comfort after installation
timeFrame: Immediately after the initial installation and adjustment
measure: Splint comfort after 30 days
timeFrame: After 30 days of use
measure: Splint stability after installation
timeFrame: Immediately after the initial installation and adjustment
measure: Splint stability after 30 days
timeFrame: After 30 days of use
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Faculdade de Odontologia. Pontifícia Universidade Católica do Rio Grande do Sul.
state: RS
Study officials:
affiliation: Pontifícia Universidade Católica do Rio Grande do Sul
name: Marcio L Grossi, PhD
role: STUDY_CHAIR
References: