Treatment for jaw pain in children and adolescents
Evaluation of Different Treatment Modalities in Children With Myalgia or Arthralgia in the Temporomandibular Region - a Randomized, Single-blinded, Controlled Non-inferiority Study
This study tests different treatments for jaw pain in kids and teens aged 7-14 to see which ones work best and if they have any side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 7 Years to 13 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Huddinge) |
| Trial ID | NCT03849534 on ClinicalTrials.gov |
What this trial studies
This project investigates the effectiveness and potential side effects of various treatment methods for temporomandibular disorders (TMD) in children and adolescents aged 7-14. The treatments include soft occlusal appliances, jaw exercises, and counseling, aimed at alleviating myalgia and arthralgia in the orofacial region. The study seeks to fill the gap in knowledge regarding the efficacy of these treatments in younger populations, as most existing evidence pertains to adults. By assessing pain intensity and treatment outcomes, the study aims to provide insights into managing TMD in this demographic.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents aged 7-14 with a diagnosis of myalgia or arthralgia and significant pain levels.
Not a fit: Patients with systemic muscular or joint diseases, neurological disorders, or pain of dental origin may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to effective treatment options for children and adolescents suffering from temporomandibular disorders, improving their quality of life.
How similar studies have performed: While there are limited high-quality studies on this topic, existing research suggests that treatment approaches for TMD in adolescents are underexplored, making this study a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Huddinge
- Karolinska Institutet, Department of Dental Medicine — Huddinge, Sweden (Recruiting)
Study contacts
- Principal investigator: Nikolaos Christidis, PhD — Karolinska Institutet, Department of Dental Medicine
- Study coordinator: Nikolaos Christidis, PhD
- Email: nikolaos.christidis@ki.se
- Phone: +46700374967
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.