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

NCT04588636 | Completed

• 1 other identifier: 10.17605/OSF.IO/9XTMD
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Myalgia of Mastication Muscle

Keywords

temporomandibular Joint Disorders; myalgia; occlusal splints; cognitive behavioral therapy; pain management

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Mandibular range of movement initial evaluation

  It was applied in the initial evaluation

• Mandibular range of movement at 2 weeks

  It was applied in week 2 of intervention.

• Mandibular range of movement at 6 weeks

  It was applied in week 6 of intervention.

• Mandibular range of movement at 10 weeks

  It was applied in week 10 of intervention.

• Mandibular functional limitation initial

  It was applied in the initial evaluation

Study Arms (4)

Behavioral and self-care therapy control group

ACTIVE COMPARATOR

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

Rigid occlusal splint group

ACTIVE COMPARATOR

Subjects in this group received behavioral and self-care therapy, in combination with a rigid occlusal splint

Behavioral: behavioral and self-care therapy; Device: rigid occlusal splint (ROS)

Soft occlusal splint group

ACTIVE COMPARATOR

Subjects in this group received behavioral and self-care therapy, in combination with a soft occlusal splint

Behavioral: behavioral and self-care therapy; Device: soft occlusal splint (SOS)

Non-occlusive splint group

PLACEBO COMPARATOR

Subjects in this group received behavioral and self-care therapy, in combination with a non-occlusive splint

Behavioral: behavioral and self-care therapy; Device: non-occlusive splint (NOS)

Interventions

behavioral and self-care therapy BEHAVIORAL

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

Also known as: BST

Behavioral and self-care therapy control group; Non-occlusive splint group; Rigid occlusal splint group; Soft occlusal splint group

rigid occlusal splint (ROS) DEVICE

Occlusal splint formed in a vacuum from rigid individual sheets of 2 mm thick polyethylene terephthalate (Biolon, Dreve, Unna, Germany).

Also known as: ROS

Rigid occlusal splint group

soft occlusal splint (SOS) DEVICE

Occlusal splint formed in a vacuum from 3 mm thick individual soft sheets of ethyl vinyl acetate (Drufosoft, Dreve, Unna, Germany).

Also known as: SOS

Soft occlusal splint group

non-occlusive splint (NOS) DEVICE

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.

Also known as: NOS

Non-occlusive splint group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Nacional Andres Bello: lead

Study Sites (1)

Universidad Nacional Andrés Bello

Viña del Mar, 2520000, Chile

Location

Related Publications (1)

• 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.

  PMID: 22809314 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Myalgia; Agnosia

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Study Officials

• Diego I De Nordenflycht

  Universidad Nacional Andrés Bello

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In the first session, operator A explained to the study subjects the alternatives, benefits and possible complications of the treatments, but it was indicated that at the time of delivery of the treatment it would not be explained to them in which group they were assigned in order to protect blinding of treatments. Operator B was in charge of delivering the treatments randomly among the subjects selected by operator A. Finally, the controls were carried out by operator A in order to protect the blinding by not knowing the treatments of the patients at the time controls.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dental surgeon

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 19, 2020
• Study Start: October 16, 2017
• Primary Completion: January 16, 2018
• Study Completion: January 16, 2018
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: One-year database availability period, starting on October 19, 2020
• 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.

Locations

CL (1)