Clinical trial NCT04588636: Behavioral Therapy and Self-care vs Thermoformed Occlusal Splints in the Treatment of Masticatory Muscles Pain
Official title: Behavioral Therapy and Self-care vs Thermoformed Occlusal Splints in the Treatment of Masticatory Muscles Pain: a Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myalgia of Mastication Muscle
Keywords: temporomandibular Joint Disorders
myalgia
occlusal splints
cognitive behavioral therapy
pain management
Lead sponsor: Universidad Nacional Andres Bello
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To protect the blinding of the study, it was carried out by two operators: A (examiner) and B (therapist). The treatment of the subjects consisted of 5 sessions: (1) evaluation and diagnosis of recruited subjects, and taking an impression of the upper jaw by operator A; (2) teaching BST and delivery of OS by operator B; (3) first treatment control and BST booster at 2 weeks; (4) second treatment control and BST booster at 6 weeks; (5) third control of treatment and removal of OS if it corresponds to 10 weeks. All controls were performed by operator A in order to use a blind design without the knowledge of the outcome assessor. To protect this, it is explained to the subject that operator A cannot know the treatment that was delivered. Operator B delivered the treatments at random among the subjects selected by operator A after the initial examination, being himself in charge of contacting them and delivering the corresponding treatment.
Primary purpose: TREATMENT

Brief summary: The objective of this study was to compare the clinical effectiveness of personalized thermoformed occlusal splints together with behavioral and self-care therapy in the management of myalgia of the masticatory muscles. A controlled clinical trial was carried out with a total of 46 subjects diagnosed with myalgia according to the diagnostic criteria for temporomandibular disorders (DC / TMD). All subjects were treated with behavioral and self-care therapy (BST) at the beginning of the study, and were then randomized into 4 groups: behavioral and self-care control group; rigid occlusal splint group; soft occlusal splint group and non-occlusive splint group. Follow-ups were carried out at 2, 6 and 10 weeks, where it was evaluated: pain in the masticatory muscles, mandibular range of motion, mandibular functional limitation and occlusal discomfort.

Detailed description: Materials and method This randomized controlled clinical trial was conducted between October 2017 and January 2018 at the Dental Clinic of the Andrés Bello University (Viña del Mar, Chile). The study subjects were recruited from the universe of patients seeking treatment for jaw pain at the School of Dentistry. All subjects were informed about the study by their operator and gave their written consent before starting the study. The protocol, design and implementation were approved by the Scientific Ethics Committee of the Faculty of Dentistry of the Andrés Bello University, Viña del Mar, Chile (Folio No. 033, October 2017). Which was in accordance with the latest version of the Declaration of Helsinki of the World Medical Association (World Medical Association Declaration of Helsinki, 2013).

Sample Size Calculation It was calculated according to a confidence level of 95% and a statistical power of 80%. Based on a previous study by Niemelä et al. (Niemelä et al., 2012) it was determined that the variance of the main variable (masticatory muscle pain) of the reference group is 2.6. In turn, the pain variable was measured on the visual analog scale (VAS), where a minimum clinically relevant difference was considered if a 3.5 point decrease was achieved on the VAS scale with respect to treatment, a reference that was also considered in this study.

Randomization and interventions. After meeting the inclusion and exclusion criteria, the subjects were randomly assigned to four groups through a computationally generated sequence "list randomizer" developed by random.org.

Evaluation methods The initial evaluation, to determine the degree of involvement of axis I, was carried out following the symptom questionnaire and clinical examination guidelines according to the DC / TMD protocol. Additionally, the questionnaire for the chronic pain degree scale (GCPS v2.0) and the functional limitation scale (JFLS-20) of axis II of the DC / TMD protocol were applied. In turn, an intraoral clinical examination was performed to exclude pain of dental origin. No subject was excluded for odontogenic pain.

Statistic analysis The demographic characteristics of the sample were reported descriptively. The data studied were tested to determine normality by using the Shapiro-Wilk and Doornik-Hansen tests, data that were parametric, so they were analyzed with a mixed ANOVA test, a factorial part and a repeated means part for the variables degree of chronic pain, masticatory muscle pain, mandibular range of motion, functional limitation and occlusal discomfort. The level of significance used was established at p 0.05. All statistical analysis was performed using Statistical Package for the Social Sciences (SPSS) version 17 software (IBM, Chicago, USA).

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 40 years
* Presence of myalgia of the masticatory muscles with or without limitation of the mouth opening according to DC / TMD diagnostic criteria

Exclusion Criteria:

* Painful joint TMD
* History of treatment for TMD
* Recent history of facial or cervical trauma
* Current orthodontic treatment
* Tooth mobility secondary to periodontal disease
* Subjects with loss of more than two teeth other than third molars and / or premolars due to orthodontic indication
* Subjects with systemic musculoskeletal diseases or who are under analgesic treatment
* Subjects with a diagnosed intellectual disability who cannot express their will to participate in scientific research as established by law 20.584 of Chile

Primary outcomes:
measure: Masticatory muscle pain initial evaluation
timeFrame: It was applied in the initial evaluation
measure: Masticatory muscle pain at 2 weeks
timeFrame: It was applied in week 2 of intervention.
measure: Masticatory muscle pain at 6 weeks
timeFrame: It was applied in week 6 of intervention.
measure: Masticatory muscle pain at 10 weeks
timeFrame: It was applied in week 10 of intervention.
Secondary outcomes:
measure: Mandibular range of movement initial evaluation
timeFrame: It was applied in the initial evaluation
measure: Mandibular range of movement at 2 weeks
timeFrame: It was applied in week 2 of intervention.
measure: Mandibular range of movement at 6 weeks
timeFrame: It was applied in week 6 of intervention.
measure: Mandibular range of movement at 10 weeks
timeFrame: It was applied in week 10 of intervention.
measure: Mandibular functional limitation initial
timeFrame: It was applied in the initial evaluation
measure: Mandibular functional limitation final
timeFrame: It was applied in week 10 of intervention.
measure: Grade of chronic pain
timeFrame: It was applied in the initial evaluation
measure: Occlusal discomfort associated with an occlusal splint at 2 weeks
timeFrame: It was applied in week 2 of intervention.
measure: Occlusal discomfort associated with an occlusal splint at 6 weeks
timeFrame: It was applied in week 6 of intervention.
measure: Occlusal discomfort associated with an occlusal splint at 10 weeks
timeFrame: It was applied in week 10 of intervention.
Other outcomes:
Locations:
city: Viña Del Mar
country: Chile
facility: Universidad Nacional Andrés Bello
Study officials:
affiliation: Universidad Nacional Andrés Bello
name: Diego I De Nordenflycht
role: PRINCIPAL_INVESTIGATOR
References:
citation: Niemela K, Korpela M, Raustia A, Ylostalo P, Sipila K. Efficacy of stabilisation splint treatment on temporomandibular disorders. J Oral Rehabil. 2012 Nov;39(11):799-804. doi: 10.1111/j.1365-2842.2012.02335.x. Epub 2012 Jul 19.