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Masticatory SystemNCT02771847

Impact of Comorbidities Among Adolescents Infected Pain Associated With Disorders of the Masticatory System

An observational study of Masticatory System, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The pain associated with disorders of the masticatory system (DAM) include pain in the masticatory muscles, temporomandibular joints, or deux.1-5 In terms of frequency, the DAM is the second musculoskeletal disorder most common behind chronic pain in the dos. Read more about this study

Who is it for?
Ages 14 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Masticatory System
What is being tested?
survey
How many people
566 participants
Where
1 siteFrance
Study dates
Feb 2015to Feb 2016
Phase
Observational
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 14 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: adolescents in 8 school in Nice

Who may be able to join

  • adolescents between 14 and 16 agree to complete an anonymous survey

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU Nice

    Nice, 06000

Other trials in France

About this study

The pain associated with disorders of the masticatory system (DAM) include pain in the masticatory muscles, temporomandibular joints, or deux.1-5 In terms of frequency, the DAM is the second musculoskeletal disorder most common behind chronic pain in the dos.

Pain associated with DAM not interested adults; they were also observed in adolescents (2-6%) with significant changes in their quality of life.8 The annual incidence of pain associated with DAM is 2.6% among adolescents and 3.9% for adults. half to two-thirds of patients affected by DAM resorted to professional care, and one-third continued to be subjected to moderate pain and incapacity to severe, regardless of treatment given.

Read more

Co-morbidities were identified in adults 12-14, children and adolescents with pain related to DAM, the United States and Suède. The most common painful co-morbidities among children and adolescents were headaches, neck, back, limbs or abdomen.

The reasons for the co-existence of DAM with other painful conditions are not well understood. Nevertheless, it has been demonstrated in adults that they contributed to apparition and persistence DAM beyond healing time conventionally predicted; they increased deterioration state health and could complicate significantly the diagnosis and efficacy of treatment.

Co-morbidity is defined as "the simultaneous existence and the occur two or more diseases, medically diagnosed in the same person.

The prevalence of several chronic painful conditions appears to be greater among people of low socioeconomic status compared with those of higher and higher socioeconomic status among women than hommes.

head pain is commonly reported in the general population (46%) The headache prevalence ranges from 9% to 97% among adults and 30% to 94% among Adolescents with DAM.

Women have a higher probability have pain related to DAM (odds ratio (OR) = 2.2, 95% confidence interval (CI): 2.1-2.4) or headache (OR = 2.5, 95% CI: 2.4-2.5) than men. Cross-sectional studies and case-control demonstrated that subjects with DAM-related pain were 1.5 to 8.8 times more likely to have headaches compared to those without pain associated with DAM.

The relationship between headaches and DAM n'est unclear. Both conditions seem to share similar pathophysiological mechanisms that would promote the development of both diseases in a individual. Patients affected by headaches are more likely to develop a DAM? A cohort study showed that adolescents affected by headaches, the chance of developing pain related to DAM was 2.7 times (95% CI: 1.6-4.4) than adolescents without headaches. Conversely, the probability of having headache increases with the number of symptoms according to a relationship of DAM.

Following the results of these studies cited before, it is now necessary to confirm the relationship between headaches and DAM among adolescents.

Neck pain and back are symptoms commonly reported in adults with DAM (35% to 44%). 23 The adults affected by DAM have smaller mobility angles in the cervical and more sensitive points to trapezoids when compared to those without DAM.

Cross-sectional studies and case-control have demonstrated that adult patients with DAM-related pain had 2.6 to 5 times more likely have back pain than individuals without pain related to DAM. Chances pain joint (OR = 4.0, 95% CI: 3.7-4.3) are larger among adults affected by DAM related pain compared to those indemnes. adults affected by DAM-related pain were also more likely to experience neck pain (OR = 4.0 to 7.9).

Adult women affected by DAM-related pain are more likely to have pain in the neck (OR = 1.5; 95% CI: 1.4-1.8) and back (OR = 1.2; 95% CI: 1.2-1.3) compared to hommes a prospective cohort study demonstrated that there was a greater likelihood of pain related to DAM among adolescents affected by back pain compared to those not affected (OR = 3.0, 95% CI: 2.2-6.8) Our study aims to seek more evidence on the supposed relationship between pain related to DAM and sore neck or back in the adolescent population.

The irritable bowel syndrome (CIS; 9% to 16%), interstitial cystitis (17%), and stomach pain (34%) are rated among adults affected by DAM. Adults affected by DAM were 2.7 times (95% CI: 1.4-5.1) more likely to have irritable bowel syndrome than subjects of the same age not affected. teenagers affected by DAM were 1.5 times (95% CI: 1.0- 2.1) over have luck stomach upset that the subjects of the same age unaffected.

Being tested
survey

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • surveyBehavioural

    anonym survey is given to people

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of painful co-morbidities of DAM among adolescents

    identification of co-morbidities by survey analyses

    Measured: 12 months

Secondary outcomes (1)
  1. number of non-painful co-morbidities of DAM among adolescents

    identification of co-morbidities by survey analyses

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2016 (estimated)
  2. Study startFeb 2015
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
566 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02771847
Sponsor's protocol ID
14-PP-14
Status last verified
May 2016
First submitted
10 May 2016
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Masticatory System, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Jun 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

number of painful co-morbidities of DAM among adolescents (time frame: 12 months). 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 16 Jun 2026.

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