Treatment of Temporomandibular Disorders in Children and Adolsecents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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

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Temporomandibular Disorder Myalgia Arthralgia of TMJ

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non-inferiority study with two patient arms that are randomized to one of three different treatment arms.

75 children with TMD myalgia are randomized to one of three treatment arms 75 children with TMD arthralgia are randomized to one of three treatment arms

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

The investigator is blinded to treatment that is performed by a specialist in orofacial pain. The patient is instructed to not reveal the treatment to the investigator

Study Groups

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Soft occlusal appliance

Individually casted appliances

Group Type ACTIVE_COMPARATOR

Soft occlusal appliance

Intervention Type DEVICE

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

Jaw exercises

Intervention Type BEHAVIORAL

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

Counseling

Intervention Type BEHAVIORAL

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

Jaw exercises

Resistance exercises to do twice a day

Group Type ACTIVE_COMPARATOR

Soft occlusal appliance

Intervention Type DEVICE

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

Jaw exercises

Intervention Type BEHAVIORAL

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

Counseling

Intervention Type BEHAVIORAL

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

Counseling

Just information at the first visit

Group Type ACTIVE_COMPARATOR

Soft occlusal appliance

Intervention Type DEVICE

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

Jaw exercises

Intervention Type BEHAVIORAL

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

Counseling

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type DEVICE

Jaw exercises

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

Intervention Type BEHAVIORAL

Counseling

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No