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NCT Number: NCT07410091

Multimodal Physiotherapy Versus Occlusal Splint in Adults With Temporomandibular Disorders

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.

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Key information

Conditions

Temporomandibular Disorders (TMD) Craniomandibular Disorders Facial Pain Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica de Fisioterapia Egas Moniz, Almada, Portugal

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Multimodal Physiotherapy

Behavioral

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 splint

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Egas Moniz - Cooperativa de Ensino Superior, CRL

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2026
Registry last updated
Mar 3, 2026

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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