Muscular TMDNCT07016256
Effect of Different Oral Splints on the Maximum Bite Force in TMD Patients
A study testing intraoral devices in people with Muscular TMD, run by Universidad Vina del Mar at 1 site in Chile.
Trial summary
The goal of this clinical trial is to evaluate whether three different types of intraoral splints can increase maximal voluntary mandibular clenching force in adults diagnosed with myogenous temporomandibular disorders (TMD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscular TMD
- What is being tested?
- intraoral devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChile
- Study dates
- 1 May 2024to 30 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with muscular TMD
- Not using ant
- Non pregnant women.
- Not under convulsive, chronic pain, antidepresive, antihypertensive, pharmacological treatments
- Without systemic pathologies.
Who cannot join
- Treatment for chronic pain, depression, hypertension, convulsion condition with or without medication.
- Regular use of benzodiazepines.
- Systemic pathologies
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evaluate whether three different types of intraoral splints can increase maximal voluntary mandibular clenching force in adults diagnosed with myogenous temporomandibular disorders (TMD). The main questions it aims to answer are:
Do intraoral splints enhance maximal clenching force in patients with muscle-related TMD? Is there a difference in the effectiveness of the three splint designs in improving muscle strength? Researchers will compare the effects of each splint within the same participants to determine which one most effectively increases clenching force.
Read more
Participants will:
Undergo baseline assessment of maximal mandibular clenching force Use each intraoral splint for a 30-day period Complete follow-up assessments after each intervention phase
Read the detailed description
This clinical trial aims to evaluate the effect of three different types of intraoral splints on maximal voluntary bite force in patients diagnosed with myogenous temporomandibular disorders (TMD). A total of 150 participants were recruited, consisting of 75 men and 75 women. Each gender group was evenly divided into three intervention arms:
25 participants received the Lucia Jig splint 25 participants received the Sved splint 25 participants received the Occlusal splint All participants were previously diagnosed with muscle-related TMD by a qualified clinician. Each participant served as their own control. Baseline measurements of maximum bite force were recorded prior to the intervention using a gnatodynamometer (Kratos, Brazil). Measurements were taken in two anatomical zones: the incisal zone and the molar zone.
For each zone, three consecutive bite force measurements were recorded, with a 5-minute rest interval between each trial. The average of the three measurements was calculated and used as the baseline value for each zone.
Participants were instructed to use their assigned intraoral splint nightly for a period of 30 days. After this period, they returned for a follow-up assessment. The same measurement protocol was repeated: three bite force recordings in both the incisal and molar zones, each separated by a 5-minute interval. The average of these three post-intervention values was calculated for comparison with the baseline.
This within-subject design allows for the evaluation of changes in bite force attributable to each splint type, and for comparison across the three splint designs. The study seeks to determine whether intraoral splints can enhance muscle strength in patients with myogenous TMD, and which design is most effective in doing so.
- Conditions
- Muscular TMD
- Being tested
- intraoral devices
- Keywords
- TMD, oral splints, lucia jig, Sved splint, Occlusal splint, orofacial pain, muscular pain
- Medical subject headings
- Facial Pain, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoral devicesDevice
Intraoral devices not registed with a patent
| Study group | Role | What they receive |
|---|---|---|
| Lucia jig | Experimental | Lucia jig splint Receives: Device: intraoral devices |
| Sved splint | Experimental | Sved splint Receives: Device: intraoral devices |
| Occlusal splint | Experimental | Occlusal splint Receives: Device: intraoral devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum bite force in the incisal and molar zones
Each patient will be tested at the beginning of the clinical trial on the maximum bite force in the incisal zone, and after 30 days post splint utilization
Measured: From enrollment to 30 days after splint utilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 May 2024
- Primary completion1 Feb 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular TMDStudies 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
- Parallel groups
- Model description
- 75 men and 75 women diagnosed with muscular TMD, dividen in 3 groups (25 patients each) to evaluate 3 different oral splints on the maximum bite force
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Vina del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolás Pinto Pardo, Universidad Vina del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016256
- Sponsor's protocol ID
- UVMODO012025
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not decided yet really, so we need more time to consider that
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Oral Splints on the Maximum Bite Force in TMD Patients
- ClinicalTrials.gov ID
- NCT07016256
- Acronym / sponsor ID
- UVMODO012025
- Conditions
- Muscular TMD
- Keywords
- TMD, oral splints, lucia jig, Sved splint, Occlusal splint, orofacial pain, muscular pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Universidad Vina del MarUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 11 Jun 2025 (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.
The goal of this clinical trial is to evaluate whether three different types of intraoral splints can increase maximal voluntary mandibular clenching force in adults diagnosed with myogenous temporomandibular disorders (TMD). The main questions it aims to answer are:
Do intraoral splints enhance maximal clenching force in patients with muscle-related TMD? Is there a difference in the effectiveness of the three splint designs in improving muscle strength? Researchers will compare the effects of each splint within the same participants to determine which one most effectively increases clenching force.
Participants will:
Undergo baseline assessment of maximal mandibular clenching force Use each intraoral splint for a 30-day period Complete follow-up assessments after each intervention phase
Detailed description
This clinical trial aims to evaluate the effect of three different types of intraoral splints on maximal voluntary bite force in patients diagnosed with myogenous temporomandibular disorders (TMD). A total of 150 participants were recruited, consisting of 75 men and 75 women. Each gender group was evenly divided into three intervention arms:
25 participants received the Lucia Jig splint 25 participants received the Sved splint 25 participants received the Occlusal splint All participants were previously diagnosed with muscle-related TMD by a qualified clinician. Each participant served as their own control. Baseline measurements of maximum bite force were recorded prior to the intervention using a gnatodynamometer (Kratos, Brazil). Measurements were taken in two anatomical zones: the incisal zone and the molar zone.
For each zone, three consecutive bite force measurements were recorded, with a 5-minute rest interval between each trial. The average of the three measurements was calculated and used as the baseline value for each zone.
Participants were instructed to use their assigned intraoral splint nightly for a period of 30 days. After this period, they returned for a follow-up assessment. The same measurement protocol was repeated: three bite force recordings in both the incisal and molar zones, each separated by a 5-minute interval. The average of these three post-intervention values was calculated for comparison with the baseline.
This within-subject design allows for the evaluation of changes in bite force attributable to each splint type, and for comparison across the three splint designs. The study seeks to determine whether intraoral splints can enhance muscle strength in patients with myogenous TMD, and which design is most effective in doing so.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 75 men and 75 women diagnosed with muscular TMD, dividen in 3 groups (25 patients each) to evaluate 3 different oral splints on the maximum bite force
| Arm | Type | Receives |
|---|---|---|
| Lucia jig | Experimental | Device: intraoral devicesLucia jig splint |
| Sved splint | Experimental | Device: intraoral devicesSved splint |
| Occlusal splint | Experimental | Device: intraoral devicesOcclusal splint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with muscular TMD
- Not using ant
- Non pregnant women.
- Not under convulsive, chronic pain, antidepresive, antihypertensive, pharmacological treatments
- Without systemic pathologies.
Key exclusion criteria (4 listed)
- Treatment for chronic pain, depression, hypertension, convulsion condition with or without medication.
- Regular use of benzodiazepines.
- Systemic pathologies
- Pregnant women
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 |
|---|---|---|
| intraoral devicesIntraoral devices not registed with a patent | Device | Lucia jig, Occlusal splint, Sved splint |
Primary outcome
Maximum bite force in the incisal and molar zones
Time frame: From enrollment to 30 days after splint utilization
Each patient will be tested at the beginning of the clinical trial on the maximum bite force in the incisal zone, and after 30 days post splint utilization
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 11 Jun 2025.
- Individual participant dataSharing planned: Undecided. It is not decided yet really, so we need more time to consider that
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraoral devices in people with Muscular TMD, run by Universidad Vina del Mar at 1 site in Chile.
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 4 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 11 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 Chile. 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?
Maximum bite force in the incisal and molar zones (time frame: From enrollment to 30 days after splint utilization). 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 11 Jun 2025.