Behavioral Therapy and Self-care vs Thermoformed Occlusal Splints in the Treatment of Masticatory Muscles Pain

Study Overview
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Brief Summary
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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
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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).

Official Title
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Behavioral Therapy and Self-care vs Thermoformed Occlusal Splints in the Treatment of Masticatory Muscles Pain: a Controlled Clinical Trial.

Conditions
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Myalgia of Mastication Muscle

Intervention / Treatment
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* Behavioral: behavioral and self-care therapy
* Device: rigid occlusal splint (ROS)
* Device: soft occlusal splint (SOS)
* Device: non-occlusive splint (NOS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Behavioral and self-care therapy control group<br>Subjects received verbal and written information on the etiology and prognosis of TMDs. In addition, advice on habits and behavior changes, relaxation techniques, sleep hygiene, diet modification, thermotherapy, encouragement to practice social and aerobic activities, and how to prevent risk factors and bad habits. | Behavioral: behavioral and self-care therapy<br>* It is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses behavioral and self-care techniques to identify, correct and prevent behaviors or situations capable of altering the subject's state<br>* Other names: BST;|
| Active Comparator: Rigid occlusal splint group<br>Subjects in this group received behavioral and self-care therapy, in combination with a rigid occlusal splint | Behavioral: behavioral and self-care therapy<br>* It is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses behavioral and self-care techniques to identify, correct and prevent behaviors or situations capable of altering the subject's state<br>* Other names: BST;Device: rigid occlusal splint (ROS)<br>* Occlusal splint formed in a vacuum from rigid individual sheets of 2 mm thick polyethylene terephthalate (Biolon, Dreve, Unna, Germany).<br>* Other names: ROS;|
| Active Comparator: Soft occlusal splint group<br>Subjects in this group received behavioral and self-care therapy, in combination with a soft occlusal splint | Behavioral: behavioral and self-care therapy<br>* It is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses behavioral and self-care techniques to identify, correct and prevent behaviors or situations capable of altering the subject's state<br>* Other names: BST;Device: soft occlusal splint (SOS)<br>* Occlusal splint formed in a vacuum from 3 mm thick individual soft sheets of ethyl vinyl acetate (Drufosoft, Dreve, Unna, Germany).<br>* Other names: SOS;|
| Placebo Comparator: Non-occlusive splint group<br>Subjects in this group received behavioral and self-care therapy, in combination with a non-occlusive splint | Behavioral: behavioral and self-care therapy<br>* It is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses behavioral and self-care techniques to identify, correct and prevent behaviors or situations capable of altering the subject's state<br>* Other names: BST;Device: non-occlusive splint (NOS)<br>* non-occlusive splint formed under vacuum from individual sheets of rigid polyethylene terephthalate 2 mm thick (Biolon, Dreve, Unna, Germany), from which the occlusal surfaces were cut and incisal edges, allowing the usual occlusal contact of each subject.<br>* Other names: NOS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Masticatory muscle pain initial evaluation | Pain intensity was measured using a visual analog scale. Subjects were asked to mark the intensity of pain perceived at the time of examination. This scale has a score from 0 to 10, with 10 being the greatest pain experienced by the patient | It was applied in the initial evaluation | 
| Masticatory muscle pain at 2 weeks | Pain intensity was measured using a visual analog scale. Subjects were asked to mark the intensity of pain perceived at the time of examination. This scale has a score from 0 to 10, with 10 being the greatest pain experienced by the patient | It was applied in week 2 of intervention. | 
| Masticatory muscle pain at 6 weeks | Pain intensity was measured using a visual analog scale. Subjects were asked to mark the intensity of pain perceived at the time of examination. This scale has a score from 0 to 10, with 10 being the greatest pain experienced by the patient | It was applied in week 6 of intervention. | 
| Masticatory muscle pain at 10 weeks | Pain intensity was measured using a visual analog scale. Subjects were asked to mark the intensity of pain perceived at the time of examination. This scale has a score from 0 to 10, with 10 being the greatest pain experienced by the patient | It was applied in week 10 of intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mandibular range of movement initial evaluation | Maximum opening of the mouth in an autonomous and comfortable way, that is, without feeling pain and not assisted by the operator, measured in millimeters from incisal edge to incisal edge in the anterior teeth, compensating for the overbite | It was applied in the initial evaluation | 
| Mandibular range of movement at 2 weeks | Maximum opening of the mouth in an autonomous and comfortable way, that is, without feeling pain and not assisted by the operator, measured in millimeters from incisal edge to incisal edge in the anterior teeth, compensating for the overbite | It was applied in week 2 of intervention. | 
| Mandibular range of movement at 6 weeks | Maximum opening of the mouth in an autonomous and comfortable way, that is, without feeling pain and not assisted by the operator, measured in millimeters from incisal edge to incisal edge in the anterior teeth, compensating for the overbite | It was applied in week 6 of intervention. | 
| Mandibular range of movement at 10 weeks | Maximum opening of the mouth in an autonomous and comfortable way, that is, without feeling pain and not assisted by the operator, measured in millimeters from incisal edge to incisal edge in the anterior teeth, compensating for the overbite | It was applied in week 10 of intervention. | 
| Mandibular functional limitation initial | Scale in charge of globally assessing masticatory limitation, vertical mobility limitation, verbal and non-verbal communication limitation, included within a 20-item instrument thanks to the survey of mandibular functional limitation of the DC / TMD. This scale has a score of 0 to 10, with 10 being a severe limitation | It was applied in the initial evaluation | 
| Mandibular functional limitation final | Scale in charge of globally assessing masticatory limitation, vertical mobility limitation, verbal and non-verbal communication limitation, included within a 20-item instrument thanks to the survey of mandibular functional limitation of the DC / TMD. This scale has a score of 0 to 10, with 10 being a severe limitation | It was applied in week 10 of intervention. | 
| Grade of chronic pain | The evaluation of the chronicity of the painful clinical picture and the disability that it involves was measured using the Graded Chronic Pain Scale of the DC / TMD, where I = Low intensity pain , without disability; II = High intensity pain, without disability; III = Moderate disability; IV = Severe disability. | It was applied in the initial evaluation | 
| Occlusal discomfort associated with an occlusal splint at 2 weeks | Scale responsible for evaluating adverse effects or discomfort of the subject to the occlusal splint during treatment, using a visual analog scale. This scale has a score of 0 to 10, with 10 being the greatest discomfort experienced by the patient. | It was applied in week 2 of intervention. | 
| Occlusal discomfort associated with an occlusal splint at 6 weeks | Scale responsible for evaluating adverse effects or discomfort of the subject to the occlusal splint during treatment, using a visual analog scale. This scale has a score of 0 to 10, with 10 being the greatest discomfort experienced by the patient. | It was applied in week 6 of intervention. | 
| Occlusal discomfort associated with an occlusal splint at 10 weeks | Scale responsible for evaluating adverse effects or discomfort of the subject to the occlusal splint during treatment, using a visual analog scale. This scale has a score of 0 to 10, with 10 being the greatest discomfort experienced by the patient. | It was applied in week 10 of intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temporomandibular Joint Disorders, myalgia, occlusal splints, cognitive behavioral therapy, pain management