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Treatment of Temporomandibular Disorders in Children and Adolsecents (TMD/PED)

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ClinicalTrials.gov Identifier: NCT03849534
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
Folktandvården Stockholms län AB
Information provided by (Responsible Party):
Nikolaos Christidis, Karolinska Institutet

Brief 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.


Condition or disease Intervention/treatment Phase
Temporomandibular Disorder Myalgia Arthralgia of TMJ Device: Soft occlusal appliance Behavioral: Jaw exercises Behavioral: Counseling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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

Masking: Single (Investigator)
Masking Description: 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
Primary Purpose: Treatment
Official Title: Evaluation of Different Treatment Modalities in Children With Myalgia or Arthralgia in the Temporomandibular Region - a Randomized, Single-blinded, Controlled Non-inferiority Study
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Soft occlusal appliance
Individually casted appliances
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.

Active Comparator: Jaw exercises
Resistance exercises to do twice a day
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.

Active Comparator: Counseling
Just information at the first visit
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.




Primary Outcome Measures :
  1. Responders to treatment - median weekly pain intensity [ Time Frame: 1-6 months ]
    30% decrease in median weekly pain intensity using a numeric rating scale 0-10 rating the worst pain daily

  2. Responders to treatment - Patients global impression change scale [ Time Frame: 1-6 months ]
    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


Secondary Outcome Measures :
  1. Change in physical functioning using the Graded Chronic Painscale (GCPS) [ Time Frame: 1-6 months ]

    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.


  2. Change in emotional status [ Time Frame: 1-6 months ]
    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.

  3. Daily activities [ Time Frame: 1-6 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849534


Contacts
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Contact: Nikolaos Christidis, PhD +46700374967 nikolaos.christidis@ki.se
Contact: Sofia Louca Jounger, PhD +46852488229 sofia.louca@ki.se

Locations
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Sweden
Karolinska Institutet, Department of Dental Medicine Recruiting
Huddinge, Sweden, 141 04
Contact: Nikolaos Christidis, PhD, DDS    +46852488000    nikolaos.christidis@ki.se   
Principal Investigator: Nikolaos Christidis, PhD, DDS         
Sub-Investigator: Georgios Tsilingaridis, Professor         
Sub-Investigator: Idil Alatli Burt, PhD, DDS         
Sub-Investigator: Sofia Louca, PhD, DDS         
Sub-Investigator: Raghdah Abduljabbar, DDS         
Sponsors and Collaborators
Karolinska Institutet
Folktandvården Stockholms län AB
Investigators
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Principal Investigator: Nikolaos Christidis, PhD Karolinska Institutet, Department of Dental Medicine

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Responsible Party: Nikolaos Christidis, Associate professor, Senior Lecturer, Senior Consultant, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03849534     History of Changes
Other Study ID Numbers: BettfysPed
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nikolaos Christidis, Karolinska Institutet:
Children
Mixed dentition
Primary dentition
Adolescents
Myalgia
Arthralgia of TMJ
Treatment
Side-effects
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Neuromuscular Diseases
Nervous System Diseases
Arthralgia
Myalgia
Myofascial Pain Syndromes
Pain
Neurologic Manifestations
Signs and Symptoms
Musculoskeletal Pain
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents