Temporomandibular Disorders (TMD)NCT07410091
Multimodal Physiotherapy Versus Occlusal Splint in Adults With Temporomandibular Disorders
A study testing Multimodal Physiotherapy and Occlusal Splint in people with Temporomandibular Disorders (TMD), run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 3 sites in Portugal.
Trial summary
The aim of this study is to compare the effects of two therapeutic approaches commonly used in the management of muscular temporomandibular disorders (TMD): a multimodal physiotherapy program combining manual therapy and therapeutic exercises, and the use of an occlusal splint during sleep. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Temporomandibular Disorders (TMD)
- What is being tested?
- Multimodal Physiotherapy and Occlusal Splint
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesPortugal
- Study dates
- 23 Feb 2024to 16 Sep 2024
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals of both sexes;
- Aged 18-50 years;
- Diagnosis of muscular temporomandibular disorders (TMD) with restricted mouth opening according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD);
- Signed informed consent.
Who cannot join
- Use of orthodontic appliances;
- History of facial trauma;
- Intake of anti-inflammatory drugs or analgesics within 48 hours prior to data collection;
- Presence of arthritis, rheumatoid disease, ankylosing spondylitis, or Bell's palsy.
Trial locations and contacts
3 sites in 1 country.
Portugal3 sites
Clínica de Fisioterapia Egas Moniz
Almada, Portugal, 2825-146
Unique Smile - Clinica Médica e Dentária
Lisbon, Portugal, 1600-258
MedCenter Cascais | Clínica Dentária
Lisbon, Portugal, 2750-512
About this study
Official title: Effect Of A 6-week Multimodal Physiotherapy Programme Versus Occlusal Splint Therapy On Pain, Mouth Opening And Quality Of Life In Adults With Muscular Temporomandibular Disorders: A Controlled Clinical Trial
The aim of this study is to compare the effects of two therapeutic approaches commonly used in the management of muscular temporomandibular disorders (TMD): a multimodal physiotherapy program combining manual therapy and therapeutic exercises, and the use of an occlusal splint during sleep.
This study seeks to determine whether these interventions help reduce pain, improve mouth opening, and enhance oral health-related quality of life in adults with muscular TMD.
Read more
Participants will be assigned to one of two groups: one group will receive a six-week multimodal physiotherapy program, while the other will use an occlusal splint nightly for the same period.
Assessments will be conducted at baseline and 48 hours after completion of the intervention. The findings of this study may contribute to improving clinical management and treatment strategies for individuals with TMD.
- Conditions
- Temporomandibular Disorders (TMD)
- Being tested
- Multimodal Physiotherapy, Occlusal Splint
- Keywords
- Temporomandibular Disorders, Multimodal Physiotherapy, Occlusal Splint, Orofacial Pain
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal PhysiotherapyBehavioural
Participants received multimodal physiotherapy consisting of one 30-minute session per week for six weeks, delivered by a trained physiotherapist. The intervention included manual therapy techniques (compression and transverse and longitudinal massage of the masseter, compression of the medial pterygoid, longitudinal massage of the temporalis, and bilateral stretching of the masseter and medial pterygoid muscles) combined with therapeutic exercises focused on strengthening (resisted mouth opening, closing, and lateral movements) and motor coordination.
Occlusal SplintDevice
Participants received thermoplastic occlusal splint therapy (3 mm thickness) and were instructed to wear the device nightly during sleep for six consecutive weeks. Splint fitting and occlusal adjustments were performed by a qualified dentist to ensure proper adaptation and comfort.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Physiotherapy | Experimental | Participants received a multimodal physiotherapy program consisting of one 30-minute session per week for six weeks, delivered by a trained physiotherapist. The intervention included manual therapy techniques targeting the masticatory muscles combined with strengthening and motor coordination exercises. Receives: Behavioral: Multimodal Physiotherapy |
| Occlusal Splint | Experimental | Participants received thermoplastic occlusal splint therapy (3 mm thickness) and were instructed to wear the device nightly during sleep for six consecutive weeks. Splint fitting and occlusal adjustments were performed by a qualified dentist. Receives: Device: Occlusal Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (Numeric Pain Rating Scale - NPRS)
Pain intensity will be assessed using the Numerical Pain Rating Scale (NPRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will rate their worst pain during daily activities in the previous 24 hours.
Measured: Baseline and 6 weeks (48 hours after completion of the intervention).
Secondary outcomes (3)
Pressure Pain Threshold - PPT (Algometry)
Pressure pain threshold will be assessed using an analogue algometer applied perpendicularly to the masseter and temporalis muscles bilaterally. Three measurements will be taken at each site and the mean value will be used for analysis.
Measured: Baseline and 6 weeks (48 hours after completion of the intervention).
Mouth Opening Amplitude (Digital Caliper)
Interincisal distance will be measured in millimetres using a digital caliper during comfortable mouth opening and maximum forced mouth opening. Three trials will be recorded and the mean value will be used for analysis.
Measured: Baseline and 6 weeks (48 hours after completion of the intervention).
Oral Health-Related Quality of Life (OHIP-14)
Oral health-related quality of life will be assessed using the OHIP-14 questionnaire.Total scores range from 0 to 56, with higher scores indicating worse oral health-related quality of life.
Measured: Baseline and 6 weeks (48 hours after completion of the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start23 Feb 2024
- Primary completion16 Sep 2024
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Disorders (TMD)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a nonrandomized, parallel-group controlled clinical trial involving two intervention arms: multimodal physiotherapy and occlusal splint therapy. Participants were allocated according to clinical indication and referral by healthcare professionals. Outcome measures were collected at baseline and 48 hours after completion of the 6-week intervention.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inês Gomes, Egas Moniz - Cooperativa de Ensino Superior, CRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410091
- Sponsor's protocol ID
- CE-EgasMoniz-1276
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mestre AM, Alves PM, Cebola PM. Effect of a 6-week multimodal physiotherapy programme versus occlusal splint therapy on pain, mouth opening and quality of life in adults with muscular Temporomandibular disorders: A non-randomised controlled clinical trial. Cranio. 2026 Sep 16:1-13. doi: 10.1080/08869634.2026.2733449. Online ahead of print.
PubMed 42750297
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of A 6-week Multimodal Physiotherapy Programme Versus Occlusal Splint Therapy On Pain, Mouth Opening And Quality Of Life In Adults With Muscular Temporomandibular Disorders: A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07410091
- Acronym / sponsor ID
- CE-EgasMoniz-1276
- Conditions
- Temporomandibular Disorders (TMD)
- Keywords
- Temporomandibular Disorders, Multimodal Physiotherapy, Occlusal Splint, Orofacial Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 13 Feb 2026 (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 aim of this study is to compare the effects of two therapeutic approaches commonly used in the management of muscular temporomandibular disorders (TMD): a multimodal physiotherapy program combining manual therapy and therapeutic exercises, and the use of an occlusal splint during sleep.
This study seeks to determine whether these interventions help reduce pain, improve mouth opening, and enhance oral health-related quality of life in adults with muscular TMD.
Participants will be assigned to one of two groups: one group will receive a six-week multimodal physiotherapy program, while the other will use an occlusal splint nightly for the same period.
Assessments will be conducted at baseline and 48 hours after completion of the intervention. The findings of this study may contribute to improving clinical management and treatment strategies for individuals with TMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a nonrandomized, parallel-group controlled clinical trial involving two intervention arms: multimodal physiotherapy and occlusal splint therapy. Participants were allocated according to clinical indication and referral by healthcare professionals. Outcome measures were collected at baseline and 48 hours after completion of the 6-week intervention.
| Arm | Type | Receives |
|---|---|---|
| Multimodal Physiotherapy | Experimental | Behavioral: Multimodal PhysiotherapyParticipants received a multimodal physiotherapy program consisting of one 30-minute session per week for six weeks, delivered by a trained physiotherapist. The intervention included manual therapy techniques targeting the masticatory muscles combined with strengthening and motor coordination exercises. |
| Occlusal Splint | Experimental | Device: Occlusal SplintParticipants received thermoplastic occlusal splint therapy (3 mm thickness) and were instructed to wear the device nightly during sleep for six consecutive weeks. Splint fitting and occlusal adjustments were performed by a qualified dentist. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals of both sexes;
- Aged 18-50 years;
- Diagnosis of muscular temporomandibular disorders (TMD) with restricted mouth opening according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD);
- Signed informed consent.
Key exclusion criteria (4 listed)
- Use of orthodontic appliances;
- History of facial trauma;
- Intake of anti-inflammatory drugs or analgesics within 48 hours prior to data collection;
- Presence of arthritis, rheumatoid disease, ankylosing spondylitis, or Bell's palsy.
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 |
|---|---|---|
| Multimodal PhysiotherapyParticipants received multimodal physiotherapy consisting of one 30-minute session per week for six weeks, delivered by a trained physiotherapist. The intervention included manual therapy techniques (compression and transverse and longitudinal massage of the masseter, compression of the medial pterygoid, longitudinal massage of the temporalis, and bilateral stretching of the masseter and medial pterygoid muscles) combined with therapeutic exercises focused on strengthening (resisted mouth opening, closing, and lateral movements) and motor coordination. | Behavioural | Multimodal Physiotherapy |
| Occlusal SplintParticipants received thermoplastic occlusal splint therapy (3 mm thickness) and were instructed to wear the device nightly during sleep for six consecutive weeks. Splint fitting and occlusal adjustments were performed by a qualified dentist to ensure proper adaptation and comfort. | Device | Occlusal Splint |
Primary outcome
Pain Intensity (Numeric Pain Rating Scale - NPRS)
Time frame: Baseline and 6 weeks (48 hours after completion of the intervention).
Pain intensity will be assessed using the Numerical Pain Rating Scale (NPRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will rate their worst pain during daily activities in the previous 24 hours.
3 secondary outcomes
Pressure Pain Threshold - PPT (Algometry)
Time frame: Baseline and 6 weeks (48 hours after completion of the intervention).
Mouth Opening Amplitude (Digital Caliper)
Time frame: Baseline and 6 weeks (48 hours after completion of the intervention).
Oral Health-Related Quality of Life (OHIP-14)
Time frame: Baseline and 6 weeks (48 hours after completion of the intervention).
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 3 Mar 2026.
- Derived from this study: PubMed 42750297Mestre AM, Alves PM, Cebola PM. Effect of a 6-week multimodal physiotherapy programme versus occlusal splint therapy on pain, mouth opening and quality of life in adults with muscular Temporomandibular disorders: A non-randomised controlled clinical trial. Cranio. 2026 Sep 16:1-13. doi: 10.1080/08869634.2026.2733449. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Physiotherapy and Occlusal Splint in people with Temporomandibular Disorders (TMD), run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 3 sites in Portugal.
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 4 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 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. 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?
Pain Intensity (Numeric Pain Rating Scale - NPRS) (time frame: Baseline and 6 weeks (48 hours after completion of the intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07410091, which also lists 1 linked publication.
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 3 Mar 2026.