Temporomandibular DisorderTMD/PEDNCT03849534
Treatment of Temporomandibular Disorders in Children and Adolsecents
A study testing Soft occlusal appliance, Jaw exercises and Counseling in people with Temporomandibular Disorder and Myalgia, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Temporomandibular Disorder, Myalgia, Arthralgia of TMJ
- What is being tested?
- Soft occlusal appliance, Jaw exercises and Counseling
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Department of Dental Medicine
Huddinge, 141 04
About this study
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
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.
Read the 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
- Being tested
- Soft occlusal appliance, Jaw exercises, Counseling
- Keywords
- Children, Mixed dentition, Primary dentition, Adolescents, Myalgia, Arthralgia of TMJ, Treatment, Side-effects
- Medical subject headings
- Temporomandibular Joint Disorders, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft occlusal applianceDevice
According to Best Practice in Sweden the soft occlusal appliance is ranked as gold standard for children with mixed or primary dentition
Jaw exercisesBehavioural
The participants do three exercises twice a day. Open and closing mouth against resistance as well as stretch
CounselingBehavioural
The patients are instructed to minimize jaw parafunctions, chewing chewing gum etc, to do exercises, to take pain-killers or NSAIDs etc.
| Study group | Role | What they receive |
|---|---|---|
| Soft occlusal appliance | Active comparator | Individually casted appliances Receives: Device: Soft occlusal appliance; Behavioral: Jaw exercises; Behavioral: Counseling |
| Jaw exercises | Active comparator | Resistance exercises to do twice a day Receives: Device: Soft occlusal appliance; Behavioral: Jaw exercises; Behavioral: Counseling |
| Counseling | Active comparator | Just information at the first visit Receives: Device: Soft occlusal appliance; Behavioral: Jaw exercises; Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1-6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: 1-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Sep 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Why it stopped: Due to covid no enrollment and ethical approval has been to old and therfore not eligable any more.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Folktandvården Stockholms län AB
- Responsible party
- Principal investigator, Nikolaos Christidis, Karolinska Institutet
- Investigators
- Nikolaos Christidis, PhD, Principal investigator, Karolinska Institutet, Department of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849534
- Sponsor's protocol ID
- BettfysPed
- Acronym
- TMD/PED
- Status last verified
- May 2026
- First submitted
- 20 Feb 2019
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03849534
- Acronym / sponsor ID
- TMD/PED / BettfysPed
- Conditions
- Temporomandibular Disorder, Myalgia, Arthralgia of TMJ
- Keywords
- Children, Mixed dentition, Primary dentition, Adolescents, Myalgia, Arthralgia of TMJ, Treatment, Side-effects
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to covid no enrollment and ethical approval has been to old and therfore not eligable any more.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Folktandvården Stockholms län AB
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Soft occlusal appliance | Active comparator | Device: Soft occlusal appliance, Behavioral: Jaw exercises, Behavioral: CounselingIndividually casted appliances |
| Jaw exercises | Active comparator | Device: Soft occlusal appliance, Behavioral: Jaw exercises, Behavioral: CounselingResistance exercises to do twice a day |
| Counseling | Active comparator | Device: Soft occlusal appliance, Behavioral: Jaw exercises, Behavioral: CounselingJust information at the first visit |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
- disc displacement with or without reduction according to DC/TMD
- degenerative joint disease.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft occlusal applianceAccording to Best Practice in Sweden the soft occlusal appliance is ranked as gold standard for children with mixed or primary dentition | Device | Counseling, Jaw exercises, Soft occlusal appliance |
| Jaw exercisesThe participants do three exercises twice a day. Open and closing mouth against resistance as well as stretch | Behavioural | Counseling, Jaw exercises, Soft occlusal appliance |
| CounselingThe patients are instructed to minimize jaw parafunctions, chewing chewing gum etc, to do exercises, to take pain-killers or NSAIDs etc. | Behavioural | Counseling, Jaw exercises, Soft occlusal appliance |
Primary outcome
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
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
3 secondary outcomes
Change in physical functioning using the Graded Chronic Painscale (GCPS)
Time frame: 1-6 months
Change in emotional status
Time frame: 1-6 months
Daily activities
Time frame: 1-6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaos Christidis, PhD principal investigator
Karolinska Institutet, Department of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft occlusal appliance, Jaw exercises and Counseling in people with Temporomandibular Disorder and Myalgia, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responders to treatment - median weekly pain intensity (time frame: 1-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.