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Alternating red and infrared laser photobiomodulation therapy for temporomandibular disorders: study protocol for a randomized double-blind clinical trial

The influence of educational measures and low-level laser phototherapy on temporomandibular disorders: effects on pain, mandibular mobility and quality of life

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2bnc6y
Enrollment
Unknown
Registered
2018-04-12
Start date
2018-02-01
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

Temporomandibular Disorder

Interventions

Participants will be distributed in 4 groups, with 25 patients per group. Group 1 (control SHAM) consists of 25 patients who will receive guidance on self-control for pain in TMD, twice a week and wil
Other
E02.774
E07.632.490
F02.784.176

Sponsors

Faculdade de Odontologia da Universidade de São Paulo
Lead Sponsor
Faculdade de Odontologia da Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Participants aged between 18 and 55 years; diagnosed with myalgia and arthralgia, with or without disc displacement; reporting pain or discomfort related to the TMJ area, greater than 4 cm in a visual analogic scale; literated.

Exclusion criteria

Exclusion criteria: Participants that carry muco-supported dental prostheses, orthopedic or orthodontic appliances; whose state of health contraindicates some of the therapies; who present teeth in severe precarious conditions, as an indication of endodontic treatment; carriers of rheumatoid arthritis; who are using any analgesic or antiinflammatory medication; carriers of congenital problems with involvement of TMJ or orofacial and cervical skull region; with recent mandibular fractures; or pregnant women.

Design outcomes

Primary

MeasureTime frame
Difference in pain intensity according to a visual analogue scale of 10 cm at each stage of treatment evaluation (initial, immediately after first session, end of treatment, 30-day control).

Secondary

MeasureTime frame
Secondary outcome 1 - difference in extension of mandibular movements such as opening, right lateral, left lateral and protrusion measured in miliiters with a digital caliper at each stage of treatment evaluation (initial, immediately after the first session, end of treatment, 30-day control ).;Secondary outcome 2 - difference in pressure pain threshold on the lateral of TMJ, anterior temporalis and superficial masseter muscles bilaterally measured with an algometer (FDX 25, Pain Test, Wagner Instruments, USA) at each stage of treatment evaluation (initial, immediate after the first session, end of treatment, 30-day control).;Secondary outcome 3 - difference in overall quality of life measured with the SF-36 questionnaire at each stage of treatment evaluation (initial, immediately after the first session, end of treatment, 30-day control).;Secondary outcome 4 - difference in quality of life related to oral health measured with the OHIP-14 questionnaire at each stage of treatment evaluation (initial, immediately after the first session, end of treatment, 30-day control).;Secondary outcome 5 - difference in patient's perspiration regarding their limitation of mandibular function measured with the MFIQ questionnaire at each stage of treatment evaluation (initial, immediately after the first session, end of treatment, 30-day control).

Countries

Brazil

Contacts

Public ContactSolange de Fantini

Faculdade de Odontologia da Universidade de São Paulo

smfantin@usp.br+551130917418

Outcome results

None listed

Source: REBEC (via WHO ICTRP)