Multimodal Physiotherapy Versus Occlusal Splint in Adults With Temporomandibular Disorders

February 28, 2026 updated by: Inês Gomes, Egas Moniz - Cooperativa de Ensino Superior, CRL

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
    • Portugal
      • Almada, Portugal, Portugal, 2825-146
        • Clínica de Fisioterapia Egas Moniz
      • Lisbon, Portugal, Portugal, 1600-258
        • Unique Smile - Clinica Médica e Dentária
      • Lisbon, Portugal, Portugal, 2750-512
        • MedCenter Cascais | Clínica Dentária

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multimodal Physiotherapy
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.
Behavioral: Multimodal Physiotherapy
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.
Experimental: Occlusal Splint
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.
Device: Occlusal Splint
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 weeks (48 hours after completion of the intervention).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure Pain Threshold - PPT (Algometry)
Time Frame: Baseline and 6 weeks (48 hours after completion of the intervention).
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.
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).
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.
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).
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.
Baseline and 6 weeks (48 hours after completion of the intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egas Moniz - Cooperativa de Ensino Superior, CRL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2024

Primary Completion (Actual)

September 16, 2024

Study Completion (Actual)

September 16, 2024

Study Registration Dates

First Submitted

February 7, 2026

First Submitted That Met QC Criteria

February 7, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE-EgasMoniz-1276

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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