NCT03849534

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 7 Years – 13 Years
• Healthy volunteers: Not accepted

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.

Detailed description

It is well known that the impact of pain in the orofacial region is not only the unpleasant sensory experience but also an emotional experience with feelings of failure, misery, guilt, alienation, and co-morbid depression. TMD is a collective term embracing chronic pain conditions affecting the temporomandibular joint or the masticatory muscles as well as their associated structures. TMD has a prevalence of approximately 10-20% and is 1.5 to 2 times more prevalent in women. It is often associated with restricted mouth opening capacity, pain upon chewing, muscle soreness and headache, thus affecting quality of life considerably although it is not life threatening. The prevalence of reported chronic pain in children and adolescents is high, and similar to the prevalence in adults. The worldwide variation in the prevalence of TMD in children and adolescents ranges from 6% to 69%. Many studies reported that TMD, headache and abdominal pain are the most common chronic pain affecting children and adolescents. 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. To our knowledge the only two high-quality studies present have investigated adolescents with permanent dentition (12-19 years), but there are no studies in the growing child with primary or mixed dentition (7-14 years). Hence, there is no knowledge if there is an effective treatment and if such a treatment with a resilient occlusal appliance impair the mandibular growth in these children. Taken together there is immense need for research on treatment of children/adolescents with orofacial pain and following their growth in order to be able to provide effective and safe treatment. Also, to investigate the knowledge-base among care-givers, giving the opportunity to improve the content of the education which in turn would lead to better, faster management of these children/adolescents who actually are our future. Therefore, the aim of this non-inferiority 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. The hypotheses are that: 1) there will be no significant differences in treatment outcome between the use of a soft occlusal appliance and standardized jaw exercises in children with myalgia but that the soft occlusal appliance and the standardized jaw exercises are superior to instructions of self-care; 2) the soft occlusal appliance does not affect the mandibular growth nor the dental eruption pattern; 3) there will be no significant differences in treatment outcome between the use of a soft occlusal appliance, or NSAIDs in children with arthralgia, but that the soft occlusal appliance and the NSAIDs are superior to instructions of self-care.

Conditions

• Temporomandibular Disorder
• Myalgia
• Arthralgia of TMJ

Interventions

Type	Name	Description
DEVICE	Soft occlusal appliance	According to Best Practice in Sweden the soft occlusal appliance is ranked as gold standard for children with mixed or primary dentition
BEHAVIORAL	Jaw exercises	The participants do three exercises twice a day. Open and closing mouth against resistance as well as stretch
BEHAVIORAL	Counseling	The patients are instructed to minimize jaw parafunctions, chewing chewing gum etc, to do exercises, to take pain-killers or NSAIDs etc.

Timeline

• Start date: 2024-09-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2019-02-21
• Last updated: 2025-03-05

Locations

1 site across 1 country: Sweden