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

Plain Language Summary

Simplified for easier understanding

This study examines different treatments for temporomandibular disorders (TMD) — jaw joint and muscle pain — in children aged 7–14. TMD causes pain in the jaw, face, and head and can significantly affect a child's quality of life. Children with TMD are often undertreated because there is limited evidence for which therapies work best in pediatric patients. This trial compares different approaches including physical therapy, splints, and behavioral interventions. Participants must have confirmed myalgia (muscle pain) or arthralgia (joint pain) in the jaw area, with a pain intensity of 30 mm or more on a 100 mm scale. They will be randomly assigned to different treatment approaches and followed to compare pain reduction and functional improvement. You may be eligible if: - You are a child between 7 and 14 years old - You have been diagnosed with jaw muscle pain (myalgia) or joint pain (arthralgia) per DC/TMD criteria - Your average jaw pain is at least 30 mm on a 100 mm pain scale during the past week You may NOT be eligible if: - You have a diagnosed systemic muscle or joint disease (e.g., fibromyalgia, rheumatoid arthritis) - You have whiplash-associated disorder - You have neuropathic pain or a neurological disorder (e.g., myasthenia gravis) - You have a history of psychiatric disorders - Your pain is from a dental origin (tooth problems) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03849534


Related Trials