RecruitingNot ApplicableNCT03849534

Treatment of Temporomandibular Disorders in Children and Adolsecents

Evaluation of Different Treatment Modalities in Children With Myalgia or Arthralgia in the Temporomandibular Region - a Randomized, Single-blinded, Controlled Non-inferiority Study


Sponsor

Karolinska Institutet

Enrollment

150 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 7 YearsMax Age: 13 Years

Inclusion Criteria6

  • 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.

Exclusion Criteria4

  • 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.

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Interventions

DEVICESoft occlusal appliance

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

BEHAVIORALJaw exercises

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

BEHAVIORALCounseling

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


Locations(1)

Karolinska Institutet, Department of Dental Medicine

Huddinge, Sweden

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NCT03849534


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