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

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

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.

Study Overview

• Status: Completed
• Conditions: Myalgia of Mastication Muscle
• Intervention / Treatment: Behavioral: behavioral and self-care therapy; Device: rigid occlusal splint (ROS); Device: soft occlusal splint (SOS); Device: non-occlusive splint (NOS)

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).

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Viña Del Mar, Chile, 2520000
    • Universidad Nacional Andres Bello

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Behavioral and self-care therapy control group; 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; 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; Other Names: BST
Active Comparator: Rigid occlusal splint group; Subjects in this group received behavioral and self-care therapy, in combination with a rigid occlusal splint	Behavioral: behavioral and self-care therapy; 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; Other Names: BST; Device: rigid occlusal splint (ROS); Occlusal splint formed in a vacuum from rigid individual sheets of 2 mm thick polyethylene terephthalate (Biolon, Dreve, Unna, Germany).; Other Names: ROS
Active Comparator: Soft occlusal splint group; Subjects in this group received behavioral and self-care therapy, in combination with a soft occlusal splint	Behavioral: behavioral and self-care therapy; 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; Other Names: BST; Device: soft occlusal splint (SOS); Occlusal splint formed in a vacuum from 3 mm thick individual soft sheets of ethyl vinyl acetate (Drufosoft, Dreve, Unna, Germany).; Other Names: SOS
Placebo Comparator: Non-occlusive splint group; Subjects in this group received behavioral and self-care therapy, in combination with a non-occlusive splint	Behavioral: behavioral and self-care therapy; 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; Other Names: BST; Device: non-occlusive splint (NOS); 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.; Other Names: NOS

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Universidad Nacional Andres Bello
• Investigators: Principal Investigator: Diego I De Nordenflycht, Universidad Nacional Andres Bello

Publications and helpful links

General Publications

• 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.

Helpful Links

• The DC/TMD is intended for use in both clinical settings and applied research settings.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): January 16, 2018
• Study Completion (Actual): January 16, 2018

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: cognitive behavioral therapy; pain management; myalgia; temporomandibular Joint Disorders; occlusal splints
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia; Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: 10.17605/OSF.IO/9XTMD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All the collected individual participant data (IPD), study protocol, statistical analysis plan, informed consent form and a clinical study report will be shared, including results, discussion and bibliography studied.
• IPD Sharing Time Frame: One-year database availability period, starting on October 19, 2020
• IPD Sharing Access Criteria: Database will be shared in Open Security Foundation (OSF), a non-profit public organization founded as a support organization for open source security projects.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Study Data/Documents

1. Study Protocol
   Information identifier: 10.17605/OSF.IO/9XTMD
   Information comments: Supporting information for this study is available in the open science framework (OSF): the data set of individual participants, study protocol, statistical analysis plan, and informed consent form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No