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

Evaluation of Different Treatment Modalities in Children With Myalgia or Arthralgia in the Temporomandibular Region - a Randomized, Single-blinded, Controlled Non-inferiority Study

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.

Study Overview

• Status: Recruiting
• Conditions: Myalgia; Temporomandibular Disorder; Arthralgia of TMJ
• Intervention / Treatment: Device: Soft occlusal appliance; Behavioral: Jaw exercises; Behavioral: Counseling

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nikolaos Christidis, PhD; Phone Number: +46700374967; Email: nikolaos.christidis@ki.se
• Study Contact Backup: Name: Sofia Louca Jounger, PhD; Phone Number: +46852488229; Email: sofia.louca@ki.se

Study Locations

• Sweden
  • Huddinge, Sweden, 141 04
    • Recruiting
    • Karolinska Institutet, Department of Dental Medicine
    • Contact: Nikolaos Christidis, PhD, DDS; Phone Number: +46852488000; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	1-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	1-6 months

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Folktandvården Stockholms län AB
• Investigators: Principal Investigator: Nikolaos Christidis, PhD, Karolinska Institutet, Department of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Adolescents; Treatment; Children; Myalgia; Side-effects; Primary dentition; Mixed dentition; Arthralgia of TMJ
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Arthralgia; Myalgia; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: BettfysPed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No