BruxismNCT06518447
Conventional vs Digital CAD/CAM Splints for Bruxism
A study testing Digital occlusal splints (CAD/CAM) and Conventional occlusal splints in people with Bruxism, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Bruxism
- What is being tested?
- Digital occlusal splints (CAD/CAM) and Conventional occlusal splints
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Odontologia. Pontifícia Universidade Católica do Rio Grande do Sul.
Porto Alegre, Rio Grande do Sul, 90619-900
About this study
Official title: Randomized Cross-clinical Trial Comparing Precision of Conventional Stabilization Splints (Michigan Type) Versus CAD/CAM Splints With Fully Digital Flow
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.
- Conditions
- Bruxism
- Being tested
- Digital occlusal splints (CAD/CAM), Conventional occlusal splints
- Keywords
- occlusal splints, computer-aided design, bruxism
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital occlusal splints (CAD/CAM)Device
Also called Digital intra-oral 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.
Conventional occlusal splintsDevice
Also called Conventional intra-oral 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.
| Study group | Role | What they receive |
|---|---|---|
| Digital occlusal splints (CAD/CAM) | Experimental | Patients in this arm will receive a CAD/CAM occlusal stabilization splint created using a fully digital workflow. The process includes:
1. Digital Impression: digital scan of the mouth will be performed using a 3shape® intraoral scanner.
2. Digital Design: The scanned data will be processed using Dental Wings' DWOS® software to design the occlusal splint virtually. The design will ensure the splint follows the Michigan splint type specifications.
3. Manufacturing: The designed splint will be fabricated using a Straumann® P series rapidshape P30+ 3D printer with a specific acrylic resin, Cosmos Splint. The splint will be polished to ensure comfort and fit, while maintaining the same surface texture as the conventional splint.
4. Fitting and Adjustment: The digitally fabricated splint will be fitted and adjusted as necessary to ensure proper adaptation and occlusal contacts. An Occlusense device will be used to verify and adjust the occlusal contacts during the fitting process. Receives: Device: Digital occlusal splints (CAD/CAM) |
| Conventional occlusal splints | Active comparator | Patients in this arm will receive a conventional occlusal stabilization splint fabricated using traditional analog methods. The process includes:
1. Impression Taking: Impressions of the patient's upper and lower arches will be taken using alginate.
2. Model Preparation: The plaster models will be mounted on a semi-adjustable articulator using a centric relation occlusal record. A wax-up of the occlusal splint will be created following the Michigan splint type specifications.
3. Manufacturing: The wax-up will be processed and flasked with heat-cured acrylic resin to create the final splint. The splint will be polished similarly to the digital splint to ensure a consistent appearance and texture.
4. Fitting and Adjustment: The conventional splint will be fitted and adjusted to ensure proper adaptation and occlusal contacts. An Occlusense device will be used to verify and adjust the occlusal contacts during the fitting process. Receives: Device: Conventional occlusal splints |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of occlusal contacts
The number of occlusal contacts will be measured using the OccluSense® device
Measured: Immediately after the initial installation
Secondary outcomes (7)
Time Required for Splint Adjustment
The time required to adjust each splint during the fitting process
Measured: Immediately after the initial installation and adjustment
Participant satisfaction after installation
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.
Measured: Immediately after the initial installation and adjustment
Participant satisfaction after 30 days
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.
Measured: After 30 days of use
Splint comfort after installation
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.
Measured: Immediately after the initial installation and adjustment
Splint comfort after 30 days
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.
Measured: After 30 days of use
Splint stability after installation
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).
Measured: Immediately after the initial installation and adjustment
Splint stability after 30 days
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).
Measured: After 30 days of use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Aug 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcio L Grossi, PhD, Study chair, Pontifícia Universidade Católica do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518447
- Sponsor's protocol ID
- 59319422.3.0000.5336
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planned. Sharing of anonymized data may be considered under exceptional circumstances through direct contact with investigators.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Cross-clinical Trial Comparing Precision of Conventional Stabilization Splints (Michigan Type) Versus CAD/CAM Splints With Fully Digital Flow
- ClinicalTrials.gov ID
- NCT06518447
- Acronym / sponsor ID
- 59319422.3.0000.5336
- Conditions
- Bruxism
- Keywords
- occlusal splints, computer-aided design, bruxism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital occlusal splints (CAD/CAM) | Experimental | Device: Digital occlusal splints (CAD/CAM)Patients in this arm will receive a CAD/CAM occlusal stabilization splint created using a fully digital workflow. The process includes: 1. Digital Impression: digital scan of the mouth will be performed using a 3shape® intraoral scanner. 2. Digital Design: The scanned data will be processed using Dental Wings' DWOS® software to design the occlusal splint virtually. The design will ensure the splint follows the Michigan splint type specifications. 3. Manufacturing: The designed splint will be fabricated using a Straumann® P series rapidshape P30+ 3D printer with a specific acrylic resin, Cosmos Splint. The splint will be polished to ensure comfort and fit, while maintaining the same surface texture as the conventional splint. 4. Fitting and Adjustment: The digitally fabricated splint will be fitted and adjusted as necessary to ensure proper adaptation and occlusal contacts. An Occlusense device will be used to verify and adjust the occlusal contacts during the fitting process. |
| Conventional occlusal splints | Active comparator | Device: Conventional occlusal splintsPatients in this arm will receive a conventional occlusal stabilization splint fabricated using traditional analog methods. The process includes: 1. Impression Taking: Impressions of the patient's upper and lower arches will be taken using alginate. 2. Model Preparation: The plaster models will be mounted on a semi-adjustable articulator using a centric relation occlusal record. A wax-up of the occlusal splint will be created following the Michigan splint type specifications. 3. Manufacturing: The wax-up will be processed and flasked with heat-cured acrylic resin to create the final splint. The splint will be polished similarly to the digital splint to ensure a consistent appearance and texture. 4. Fitting and Adjustment: The conventional splint will be fitted and adjusted to ensure proper adaptation and occlusal contacts. An Occlusense device will be used to verify and adjust the occlusal contacts during the fitting process. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital occlusal splints (CAD/CAM)Also: Digital intra-oral deviceConsists 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. | Device | Digital occlusal splints (CAD/CAM) |
| Conventional occlusal splintsAlso: Conventional intra-oral deviceConsists 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. | Device | Conventional occlusal splints |
Primary outcome
Number of occlusal contacts
Time frame: Immediately after the initial installation
The number of occlusal contacts will be measured using the OccluSense® device
7 secondary outcomes
Time Required for Splint Adjustment
Time frame: Immediately after the initial installation and adjustment
Participant satisfaction after installation
Time frame: Immediately after the initial installation and adjustment
Participant satisfaction after 30 days
Time frame: After 30 days of use
Splint comfort after installation
Time frame: Immediately after the initial installation and adjustment
Splint comfort after 30 days
Time frame: After 30 days of use
Splint stability after installation
Time frame: Immediately after the initial installation and adjustment
Splint stability after 30 days
Time frame: After 30 days of use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No. Not planned. Sharing of anonymized data may be considered under exceptional circumstances through direct contact with investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcio L Grossi, PhD study chair
Pontifícia Universidade Católica do Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital occlusal splints (CAD/CAM) and Conventional occlusal splints in people with Bruxism, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of occlusal contacts (time frame: Immediately after the initial installation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.