Treatment of Temporomandibular Disorders in Children and Adolsecents

NCT03849534 | Recruiting

• 1 other identifier: BettfysPed
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Children and adolescents are treated with routine treatment approaches for adults and one of the most commonly used treatments are occlusal appliances. The use of occlusal appliances in managing orofacial pain conditions is supported by evidence, but only for adults. However, the efficacy of the treatment approaches and any possible side-effects/impairment of mandibular growth are absent. Therefore, the aim of this project is to investigate the effectiveness and possible side-effects of different treatment modalities, such as an occlusal appliance, jaw exercises, NSAID for the conditions myalgia orarthralgia in the orofacial region in children with primary or mixed dentition.

Conditions

Temporomandibular Disorder; Myalgia; Arthralgia of TMJ

Keywords

Children; Mixed dentition; Primary dentition; Adolescents; Myalgia; Arthralgia of TMJ; Treatment; Side-effects

Outcome Measures

Primary Outcomes (2)

• Responders to treatment - median weekly pain intensity

  30% decrease in median weekly pain intensity using a numeric rating scale 0-10 rating the worst pain daily

  1-6 months

• Responders to treatment - Patients global impression change scale

  The patients global impression change scale (PGIC) will be used. PGIC is a 7-point scale with the following options: 0 = eliminated, 1 = much improved, 2 = improved, 3 = unchanged, 4 = impaired, 5 = much impaired and 6 = very much impaired

  1-6 months

Secondary Outcomes (3)

• Change in physical functioning using the Graded Chronic Painscale (GCPS)

  1-6 months

• Change in emotional status

  1-6 months

• Daily activities

  1-6 months

Study Arms (3)

Soft occlusal appliance

ACTIVE COMPARATOR

Individually casted appliances

Device: Soft occlusal appliance; Behavioral: Jaw exercises; Behavioral: Counseling

Jaw exercises

ACTIVE COMPARATOR

Resistance exercises to do twice a day

Device: Soft occlusal appliance; Behavioral: Jaw exercises; Behavioral: Counseling

Counseling

ACTIVE COMPARATOR

Just information at the first visit

Device: Soft occlusal appliance; Behavioral: Jaw exercises; Behavioral: Counseling

Interventions

Soft occlusal appliance DEVICE

According to Best Practice in Sweden the soft occlusal appliance is ranked as gold standard for children with mixed or primary dentition

Counseling; Jaw exercises; Soft occlusal appliance

Jaw exercises BEHAVIORAL

The participants do three exercises twice a day. Open and closing mouth against resistance as well as stretch

Counseling; Jaw exercises; Soft occlusal appliance

Counseling BEHAVIORAL

The patients are instructed to minimize jaw parafunctions, chewing chewing gum etc, to do exercises, to take pain-killers or NSAIDs etc.

Counseling; Jaw exercises; Soft occlusal appliance

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 7-14 years
• a diagnosis of myalgia or arthralgia according to DC/TMD
• self-assessed average TMD pain intensity of ≥ 30 mm on a 100-mm visual analogue scale (VAS) during one week prior to examination.
• The patients will remain included with one or several co-diagnoses of:
• disc displacement with or without reduction according to DC/TMD
• degenerative joint disease.

You may not qualify if:

• diagnosed systemic muscular or joint diseases (e.g. fibromyalgia, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis)
• whiplash associated disorder (WAD)
• neuropathic pain or neurological disorders (e.g. myasthenia gravis, orofacial dystonia)
• history of psychiatric disorders, and 5) pain of dental origin.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Folktandvården Stockholms län AB: collaborator

Study Sites (1)

Karolinska Institutet, Department of Dental Medicine

Huddinge, 141 04, Sweden

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Myalgia

Interventions

Counseling

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

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nikolaos Christidis, PhD

  Karolinska Institutet, Department of Dental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolaos Christidis, PhD

CONTACT

+46700374967; nikolaos.christidis@ki.se

Sofia Louca Jounger, PhD

CONTACT

+46852488229; sofia.louca@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator is blinded to treatment that is performed by a specialist in orofacial pain. The patient is instructed to not reveal the treatment to the investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Senior Lecturer, Senior Consultant

Model Details: Non-inferiority study with two patient arms that are randomized to one of three different treatment arms. 75 children with TMD myalgia are randomized to one of three treatment arms 75 children with TMD arthralgia are randomized to one of three treatment arms

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 21, 2019
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

SE (1)