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Do the characteristics of the Bite-Stabilizing Plate change depending on how it is printed?

Prosthetic properties of the Interocclusal Stabilizing Device, do they change according to the impression angle? A randomized crossover blind clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8wdrwhs
Enrollment
Unknown
Registered
2023-06-23
Start date
2023-09-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Sleep Bruxism

Interventions

This is a blinded crossover randomized clinical trial that will be carried out at the center specializing in Orofacial Pain and Temporomandibular Disorders at the Federal University of Uberlândia from
2. Compare whether the number and distribution of contact points in static and dynamic occlusion are interfered with by the impression angle of the Interocclusal Stabilizer Device
3. Analyze patient preferences regarding retention, stability, comfort, need for adjustment, fracture, prosthetic quality, staining, and final choice. Interocclusal Stabilizer Devices for patients ove
the confection will be divided into two groups according to the printing angle: 90° group (G90) and 45° group (G45) n = 20. Geomagic Control 3D Systems software will be used to superimpose digital fil
occlusion analysis for the second, and a questionnaire with responses in Likert format for the third. Randomization: randomization stratified by blocks in excel will be performed, considering the diag

Sponsors

Universidade Federal de Uberlândia - Faculdade de Odontologia
Lead Sponsor
Universidade Federal de Uberlândia - Faculdade de Odontologia
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with a probable diagnosis of Sleep Bruxism (SB); with discomfort in the masticatory muscles; apparent hypertrophy of the masseter; history of teeth grinding during the night; healthy oral mucosa, absence of systemic diseases; the autonomy of behavior and expression; both genders; over 18 years old

Exclusion criteria

Exclusion criteria: Patients diagnosed with moderate and severe Obstructive Sleep Apnea; absence of one or more molars; patients with upper removable dental prostheses; patients undergoing orthodontic treatment; patients with neurological disorders

Design outcomes

Primary

MeasureTime frame
It is expected to find uniform wear on the Interocclusal Stabilizer Device both at 90° and at 45°, verified using the method of superimposing digital files in the Geomagic Control 3D Systems software, from a 30 µm difference in wear as a cutting measure;It is expected to find a uniform number and distribution of contact points on the Interocclusal Stabilizer Device both at 90° and at 45°, verified using the static and dynamic occlusal analysis method, considering one contact point per tooth as a minimum

Secondary

MeasureTime frame
It is expected to find no clinically relevant difference in the patient's perception of making the Interocclusal Stabilizer Device at 90° and 45°, verified through the application of questionnaires with seven questions after using each one

Countries

Brazil

Contacts

Public ContactBetty Mayta

Universidade Federal de Uberlândia

betty.mayta@ufu.br+55(34)997297964

Outcome results

None listed

Source: REBEC (via WHO ICTRP)