An interventional study of Soft occlusal appliance and Jaw exercises in Temporomandibular Disorder, Myalgia and Arthralgia of TMJ, sponsored by Karolinska Institutet. Withdrawn at 1 site in Sweden. Open to participants aged 7 Years to 13 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
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.
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
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The patients will remain included with one or several co-diagnoses of:
Exclusion Criteria:
Individually casted appliances
Device: Soft occlusal appliance · Behavioral: Jaw exercises · Behavioral: Counseling
Resistance exercises to do twice a day
Device: Soft occlusal appliance · Behavioral: Jaw exercises · Behavioral: Counseling
Just information at the first visit
Device: Soft occlusal appliance · Behavioral: Jaw exercises · Behavioral: Counseling
According to Best Practice in Sweden the soft occlusal appliance is ranked as gold standard for children with mixed or primary dentition
The participants do three exercises twice a day. Open and closing mouth against resistance as well as stretch
The patients are instructed to minimize jaw parafunctions, chewing chewing gum etc, to do exercises, to take pain-killers or NSAIDs etc.
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
Time frame: 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
Time frame: 1-6 months
Change in physical functioning using the Graded Chronic Painscale (GCPS)
The graded chronic pain scale include 3 questions regarding pain intensity and 3 questions regarding physical functioning. The mean of the 3 questions regarding provide us with the characteristic pain intensity while the mean of the physical functgioning questions together with sick leave (from work/school) provide us with information about how pain affects physical functioning. Characteristic pain intensity ranges from 0-100 while physical functioning is graded from 0-IV. The lower, the better outcome for all subscales. GCPS is a stanrd tool in the Diagnostic Criteria for temporomandibular disorders (DC/TMD) and part of Axis II which also the questionnaires for the emotional status in Oiutcome 3 are.
Time frame: 1-6 months
Change in emotional status
Changed scores in questionnaires from Axis II in DC/TMD, including stress using the Perceived Stress Scale-4 (PSS-4), anxiety/depression using the Patient Health Questionnaire-4 (PHQ-4) and the psychosocial situation using the Youth Self-report (YSR) Lower scores in these questionnair represent a better outcome The PSS and PHQ-scales are not combained and ranges from 0-4 for each questions. The YSR is based on several subscales, including the DCM-IV.
Time frame: 1-6 months
Daily activities
This outcome is based on a daily question of school attendance as well as free-time activities. The question is did you attend at school today or did you stay at home due to your orofacial pain. Question 2. Did you do your free-time activity or did you stay at hom due to your orofacial pain
Time frame: 1-6 months
Started Sep 2024 (actual). Primary completion is estimated for Dec 2028, 51 months after the start.
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This study is withdrawn, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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