Clinical trial NCT03096301: Photobiomodulation in Temporomandibular Disorder
Official title: Photomodulation in the Treatment of Pain in Patients With Tmd: Analysis of Cost-effectiveness.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Temporomandibular Disorder
Keywords: temporomandibular disorder
photobiomodulation
pain
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 45
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a prospective trial of clinical and economic analysis. It will include 45 patients to evaluate the effectiveness of the treatments with low-intensity laser and occlusal plate for muscle pain in patients with TMD
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The general purpose of this project is to evaluate the cost-effectiveness of LIL treatment and occlusal plates in the treatment of pain in patients between 15 and 25 years of age with TMD.

Detailed description: Temporomandibular disorder (TMD) affects a significant portion of the population. Epidemiological data show that the signs and symptoms of TMD start to become apparent from six years of age, and in adolescence these signs and symptoms are similar to those of adults. The painful conditions of TMD can affect the quality of life of young patients, compromising the daily activities of these individuals. The present project aims (1) to estimate the direct costs of treatment of muscle pain in patients with TMD with low-intensity laser and with occlusal plate and a placebo group; (2) to evaluate the effectiveness of the treatments with low-intensity laser and occlusal plate for muscle pain in patients with TMD; (3) to analyze the cost-effectiveness of the two proposed treatments for pain; and (4) to describe and compare the results of analyses of treatments for pain in patients with TMD. The study will be conducted at the Odontological Clinic of Universidade Nove de Julho. It is a prospective trial of clinical and economic analysis. It will include 30 patients aged between 15 and 25 years with TMD, randomly assigned to a treatment group: G1 (low-power laser), G2 (occlusal plate) and G3 (placebo). The analysis will be based on the direct costs of each treatment during the 12-month period, estimating the cost of each treatment. The outcome for the analysis of the effectiveness will be the pain, measured periodically by means of the clinical examination of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). The cost-effectiveness ratio will be calculated using, as endpoints, pain and the calculation of the ratio between the difference in costs between the groups studied. The evaluation of the impact of the treatment on quality of life will be determined by applying the adapted EuroQol-5D.

Eligibility criteria: Inclusion Criteria:

* people between 15 and 25 years
* diagnosis of TMD in group I

Exclusion Criteria:

* Individuals with dental-facial anomalies
* orthodontic or orthopedic treatment
* Individuals who were taking muscle relaxants or anti-inflammatory medications

Primary outcomes:
measure: Pain
timeFrame: 12 months after treatment
Secondary outcomes:
measure: Cost-effectviness
timeFrame: 12 months after treatment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Lara Motta
state: Sao Paulo
Study officials:
References:
citation: Sobral APT, Godoy CLH, Fernandes KPS, Bussadori SK, Ferrari RAM, Horliana ACRT, Monken SF, Motta LJ. Photomodulation in the treatment of chronic pain in patients with temporomandibular disorder: protocol for cost-effectiveness analysis. BMJ Open. 2018 May 5;8(5):e018326. doi: 10.1136/bmjopen-2017-018326.