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Multimodal Physiotherapy Versus Occlusal Splint in Adults With Temporomandibular Disorders

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07410091
Enrollment
24
Registered
2026-02-13
Start date
2024-02-23
Completion date
2024-09-16
Last updated
2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Disorders (TMD)

Keywords

Temporomandibular Disorders, Multimodal Physiotherapy, Occlusal Splint, Orofacial Pain

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.

Interventions

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.

DEVICEOcclusal 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.

Sponsors

Egas Moniz - Cooperativa de Ensino Superior, CRL
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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.

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026