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Low Power Laser, therapeutic ultrasound and artificial intelligence in arthralgia and temporomandibular disorders: randomized clinical trial

Photobiomodulation, therapeutic Ultrasound and Artificial Intelligence in arthralgias and Temporomandibular Myogenic Disorders: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9g8mrfg
Enrollment
Unknown
Registered
2024-12-06
Start date
2023-07-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Facial Pain

Interventions

This is a three-arm, unblinded, randomized controlled clinical study. The sample consists of 60 participants divided equally into 3 groups: Group 1- orofacial myofunctional therapy combined with phot
Group 2 – orofacial myofunctional therapy combined with therapeutic ultrasound and Group 3 – control group orofacial myofunctional therapy. The intervention includes three modalities with the followi
stretching and relaxing exercises for the jaw elevator muscles, jaw opening, lateralization and protrusion exercises
isometric and isotonic buccinator, lip and tongue exercises, functional chewing training
2) photobimodulation - applied to the demarcated points of the masseter and temporalis, bilaterally. The photobiomodulation device emits infrared radiation with a wavelength of 808 nm and an intensity
3) Ultrasonography at a frequency of 3 MHz with an intensity of 1.3 W/cm2 and continuously in the masseter and temporomandibular joint regions. The interventions will be carried out over four consecut
E02.594.540

Sponsors

Centro de Ciência da Saúde da Universidade Federal da Paraíba
Lead Sponsor
Universidade Federal da Paraíba
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Women aged 18 to 55 years who are diagnosed with joint or muscular temporomandibular disorder according to the Diagnostic Criteria for Temporomandibular Disorders DC/TMD; women who are not pregnant and/or who use a pacemaker; without rheumatological diseases; individuals who do not have cognitive deficits; individuals who do not have syndromes; do not use pain medications during the research period; onset of symptoms of at least 6 months; VAS visual analogue scale less than 7; agree and sign the Informed Consent Form (TCLE)

Exclusion criteria

Exclusion criteria: All patients who do not comply with all steps of the research protocol; patients who withdraw from the research

Design outcomes

Primary

MeasureTime frame
Avaliar intensidade da dor, espera-se encontrar diminuição da intensidade da dor pós intervenção. O método utizado para avaliar a intensidade da dor será a algometria (algmetro digital de pressão, modelo FPX)e escala visual analógica (EVA). Espera-se encontrar aumento do numero da algometria em relação ao pré e pós terapia, já na escala visual analógica, epera-se uma dimuição da dor com relação a marcação do pré e pós terapia, a partir da constatação de uma variação de pelo menos 5% nas medições pré e pós-intervenção.

Secondary

MeasureTime frame
Assess the thermoactive points on the face, it is expected to find a reduction in thermoactive points after the intervention. The method used to evaluate the thermoactive points on the face will be flir C2-X model thermography, thermographic evaluation will be carried out before and after carrying out the therapeutic intervention. A reduction in thermoactive points on the face post-intervention is expected, based on a variation of at least 5% in pre- and post-intervention measurements.;Evaluate the range of mandibular movements, it is expected to find more range of mandibular movements after intervention. The method used to evaluate mandibular movements will be carried out with a caliper, the evaluation of mandibular movements will be carried out before and after the therapeutic intervention with the verification of opening and lateralization movements.;Assess chewing performance, it is expected to find changes in chewing in the pre-therapy assessment. The method used to evaluate masticatory performance will be carried out using the amiofe protocol with an emphasis on stomatognathic functions. Assessment with the amiofe protocol will be carried out before starting therapy and reassessment will be carried out after the last therapy session. It is expected to find better chewing performance at the end of the research.

Countries

Brazil

Contacts

Public ContactBruna Rodrigues

Ministério da Ciência Tecnologia e Inovação

bruna_alves.sb.pb@hotmail.com+55-83-999290172

Outcome results

None listed

Source: REBEC (via WHO ICTRP)