Multimodal Physiotherapy Versus Occlusal Splint in Adults With Temporomandibular Disorders

NCT07410091 — Not applicable, Completed, 24 participants, Egas Moniz - Cooperativa de Ensino Superior, CRL

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07410091
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	24 (Actual)
Sponsor	Egas Moniz - Cooperativa de Ensino Superior, CRL (Other)
Conditions	Temporomandibular Disorders (TMD)
Interventions	Multimodal Physiotherapy, Occlusal Splint (Behavioral, device)
Dates	start 2024-02-23, primary completion 2024-09-16, completion 2024-09-16, first posted 2026-02-13, last updated 2026-03-03
Locations	3 sites in Portugal

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Multimodal Physiotherapy	Experimental	Behavioral: 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.
Occlusal Splint	Experimental	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.

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.

+Outcome measures

Primary outcomes

Pain Intensity (Numeric Pain Rating Scale - NPRS) [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

Pressure Pain Threshold - PPT (Algometry) [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.
Mouth Opening Amplitude (Digital Caliper) [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.
Oral Health-Related Quality of Life (OHIP-14) [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.

+Eligibility

Sex: All, ages: 18 Years to 50 Years

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.

+Locations (3)

Facility	City	Country
Clínica de Fisioterapia Egas Moniz	Almada, Portugal	Portugal
Unique Smile - Clinica Médica e Dentária	Lisbon, Portugal	Portugal
MedCenter Cascais \| Clínica Dentária	Lisbon, Portugal	Portugal

+Publications

Results publication: 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. PMID 42750297