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OpenTrials
Completed

NCT Number: NCT06518447

Conventional vs Digital CAD/CAM Splints for Bruxism

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.

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Key information

Conditions

Bruxism Behavior Habits Stomatognathic Diseases Tooth Diseases

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculdade de Odontologia. Pontifícia Universidade Católica do Rio Grande do Sul.

Porto Alegre, Rio Grande do Sul, 90619-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digital occlusal splints (CAD/CAM)

Device

Consists of occlusal stabilization intra-oral splints fabricated using a fully digital workflow, involving intraoral scanning, virtual design, and 3D printing to ensure precise fit and comfort.

Other names: Digital intra-oral device

Conventional occlusal splints

Device

Consists of occlusal stabilization splints fabricated using traditional analog methods, including physical impressions, plaster models, and manual processing with heat-cured acrylic resin to achieve the desired occlusal arrangement.

Other names: Conventional intra-oral device

Primary outcomes

  1. Number of occlusal contacts

    Time frame: Immediately after the initial installation

    The number of occlusal contacts will be measured using the OccluSense® device

Secondary outcomes

  1. Time Required for Splint Adjustment

    Time frame: Immediately after the initial installation and adjustment

    The time required to adjust each splint during the fitting process

  2. Participant satisfaction after installation

    Time frame: Immediately after the initial installation and adjustment

    Patients will assess their overall satisfaction with the splints using a 5-point Likert scale, with 1 meaning the lowest score of satisfaction and 5 meaning the highest score of satisfaction.

  3. Participant satisfaction after 30 days

    Time frame: After 30 days of use

    Patients will assess their overall satisfaction with the splints using a 5-point Likert scale, with 1 meaning the lowest score of satisfaction and 5 meaning the highest score of satisfaction.

  4. Splint comfort after installation

    Time frame: Immediately after the initial installation and adjustment

    Patients will assess comfort with the splints using a 5-point Likert scale, with 1 indicating the lowest level of comfort and 5 indicating the highest level of comfort.

  5. Splint comfort after 30 days

    Time frame: After 30 days of use

    Patients will assess comfort with the splints using a 5-point Likert scale, with 1 indicating the lowest level of comfort and 5 indicating the highest level of comfort.

  6. Splint stability after installation

    Time frame: Immediately after the initial installation and adjustment

    Patients will assess the stability of the splints (retention) during use using a 5-point Likert scale, with 1 indicating the lowest level of stability (frequent movement) and 5 indicating the highest level of stability (no movement).

  7. Splint stability after 30 days

    Time frame: After 30 days of use

    Patients will assess the stability of the splints (retention) during use using a 5-point Likert scale, with 1 indicating the lowest level of stability (frequent movement) and 5 indicating the highest level of stability (no movement).

Sponsors and collaborators

Lead sponsor

Pontificia Universidade Católica do Rio Grande do Sul

Other

Registry information

Official study title

Randomized Cross-clinical Trial Comparing Precision of Conventional Stabilization Splints (Michigan Type) Versus CAD/CAM Splints With Fully Digital Flow

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2024
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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