Multimodal Physiotherapy Versus Occlusal Splint in Adults With Temporomandibular Disorders

NCT07410091 | Completed

• 1 other identifier: CE-EgasMoniz-1276
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Temporomandibular Disorders (TMD)

Keywords

Temporomandibular Disorders; Multimodal Physiotherapy; Occlusal Splint; Orofacial Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 weeks (48 hours after completion of the intervention).

Secondary Outcomes (3)

• Pressure Pain Threshold - PPT (Algometry)

  Baseline and 6 weeks (48 hours after completion of the intervention).

• Mouth Opening Amplitude (Digital Caliper)

  Baseline and 6 weeks (48 hours after completion of the intervention).

• Oral Health-Related Quality of Life (OHIP-14)

  Baseline and 6 weeks (48 hours after completion of the intervention).

Study Arms (2)

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.

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.

Device: Occlusal Splint

Interventions

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.

Multimodal Physiotherapy

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.

Occlusal Splint

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead

Study Sites (3)

Clínica de Fisioterapia Egas Moniz

Almada, Portugal, 2825-146, Portugal

Location

Unique Smile - Clinica Médica e Dentária

Lisbon, Portugal, 1600-258, Portugal

Location

MedCenter Cascais | Clínica Dentária

Lisbon, Portugal, 2750-512, Portugal

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Facial Pain

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2026
• First Posted: February 13, 2026
• Study Start: February 23, 2024
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (3)