Temporomandibular Joint DisordersMAPANCT03139994
Altered MAstication Contribute to TMJ PAin
An observational study of Temporomandibular Joint Disorders and Mastication Disorder, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
The cause of temporomandibular joint disorders remains unknown. It is considered multifactorial and includes physical (peripheral) and psychosocial (central) factors. It has been showed an association: a steeper condylar path, flatter lateral anterior guidance, and habitual chewing on the symptomatic side. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders, Mastication Disorder
- What is being tested?
- Diagnostic
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 2 May 2017to 30 Oct 2018
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Medical or Dental School students. Healthy young adults with fully dentate normal occlusion
Who may be able to join
- healthies
- full dentates
- normal occlusion
- One habitual chewing side
Who cannot join
- Severe malocclusion, dental decay, severe periodontal disease.
- Pains from other origins or Orthodontics are not criteria for exclusion
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Santiago de Compostela
Santiago de Compostela, A Coruña, 15702
About this study
Official title: One Habitual Chewing Side May Contribute to Chronic Temporomandibular Joint Disorder Pain
The cause of temporomandibular joint disorders remains unknown. It is considered multifactorial and includes physical (peripheral) and psychosocial (central) factors. It has been showed an association: a steeper condylar path, flatter lateral anterior guidance, and habitual chewing on the symptomatic side. This finding argues the possibility of causation of some of these characteristics. This double blind longitudinal study aims to assess if the presence of one habitual chewing side could contribute to temporomandibular joint disorders over time.
Method. Young adults with no signs or symptoms of TMD will be assessed. Participants with one chewing side (observed and interview); with steeper condylar path and lower lateral guidance angles will be considered consistent one side chewers, and this side will be considered more susceptible to suffer TMD. Mouth opening, hemispheric dominance and hemimandibular retrognathia will be considered as secondary pre-specified outcomes. Four years later, both TMJs of each participant presenting signs and/or symptoms will be evaluated according to DC/TMD.
- Being tested
- Diagnostic
- Keywords
- occlusion, pain
- Medical subject headings
- Temporomandibular Joint Disorders, Bites and Stings, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnosticOther
OBSERVATIONAL, DIAGNOSTIC PROCEDURES. Young adults with no signs or symptoms of TMD will be assessed. The chewing function, condylar path angles and lateral guidance angles will be recorded. Maximum comfortable and unassisted jaw opening, hemispheric dominance and hemimandibular retrognathia will be considered as secondary pre-specified outcomes. Three-Four years later, both TMJs of each participant presenting signs and/or symptoms will be evaluated according to DC/TMD. Same recordings as baseline will be carried out.
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or not of symptoms of temporomandibular joint disorders according to DC/TMD
Pain-intensity (0-10 VAS scale, Von Korf)
Measured: At 3 years follow-up
Change of maximal unassited jaw opening
Maximum unassisted jaw opening or interincisal distance (from edge to edge) measured by a Boley gauge. Up 38 in females and up 40 mm in males are considered limited.
Measured: Baseline and 3 years follow-up
Secondary outcomes (5)
Change of condylar paths angles inclination
Alteration of parasagittal plane Axiography of condyle motion in respect Frankfort horizontal plane
Measured: Baseline and 3-4-years follow-up (end of the study)
Alteration of lateral dental guidance angles
Angle between Frankfort plane and lateral dental anterior guidance
Measured: Baseline and 4-years follow-up (end of the study)
Change of maximal comfortable jaw opening
Maximum jaw opening or interincisal distance (from edge to edge) measured by a Boley gauge. Up 38 in females and up 40 mm in males are considered limited.
Measured: Baseline and 4-years follow-up (end of the study)
Change of the habitual chewing side
Determining the habitual chewing side by direct observation using chewing gum, First cicle, and subsequent cicles (7 or over of 10 cicles), interview (used one habitual chewing side?: 1, no, alternate; 2, yes, right; 3, yes, left; 4, I don't know) and kinesiography.
Measured: Baseline and 3-4-years follow-up (end of the study)
Change of lateral deviation during maximal unassisted jaw opening
Kiesiography K7
Measured: Baseline, 3 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start2 May 2017
- Primary completion15 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Urbano Santana Penin, MD, DDS, PhD, University of Santiago de Compostela
- Investigators
- Urbano Santana-Mora, PhD, Principal investigator, University of Santiago de Compostela. SpainUrbano Santana, Prof., Study chair, University of Santiago de Compostela. SpainMª Jesús Mora, Principal investigator, University of Santiago de Compostela. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139994
- Sponsor's protocol ID
- 20130123
- Acronym
- MAPA
- Status last verified
- Sep 2021
- First submitted
- 10 May 2016
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be shared in a on-line appendix linked from the article in a JCR Journal.
Publications
Santana-Mora U, Lopez-Cedrun J, Mora MJ, Otero XL, Santana-Penin U. Temporomandibular disorders: the habitual chewing side syndrome. PLoS One. 2013 Apr 8;8(4):e59980. doi: 10.1371/journal.pone.0059980. Print 2013.
PubMed 23593156
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Habitual Chewing Side May Contribute to Chronic Temporomandibular Joint Disorder Pain
- ClinicalTrials.gov ID
- NCT03139994
- Acronym / sponsor ID
- MAPA / 20130123
- Keywords
- occlusion, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 4 May 2017 (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.
The cause of temporomandibular joint disorders remains unknown. It is considered multifactorial and includes physical (peripheral) and psychosocial (central) factors. It has been showed an association: a steeper condylar path, flatter lateral anterior guidance, and habitual chewing on the symptomatic side. This finding argues the possibility of causation of some of these characteristics. This double blind longitudinal study aims to assess if the presence of one habitual chewing side could contribute to temporomandibular joint disorders over time.
Method. Young adults with no signs or symptoms of TMD will be assessed. Participants with one chewing side (observed and interview); with steeper condylar path and lower lateral guidance angles will be considered consistent one side chewers, and this side will be considered more susceptible to suffer TMD. Mouth opening, hemispheric dominance and hemimandibular retrognathia will be considered as secondary pre-specified outcomes. Four years later, both TMJs of each participant presenting signs and/or symptoms will be evaluated according to DC/TMD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Medical or Dental School students. Healthy young adults with fully dentate normal occlusion
Key inclusion criteria (4 listed)
- healthies
- full dentates
- normal occlusion
- One habitual chewing side
Key exclusion criteria (2 listed)
- Severe malocclusion, dental decay, severe periodontal disease.
- Pains from other origins or Orthodontics are not criteria for exclusion
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 |
|---|---|---|
| DiagnosticOBSERVATIONAL, DIAGNOSTIC PROCEDURES. Young adults with no signs or symptoms of TMD will be assessed. The chewing function, condylar path angles and lateral guidance angles will be recorded. Maximum comfortable and unassisted jaw opening, hemispheric dominance and hemimandibular retrognathia will be considered as secondary pre-specified outcomes. Three-Four years later, both TMJs of each participant presenting signs and/or symptoms will be evaluated according to DC/TMD. Same recordings as baseline will be carried out. | Other | – |
Primary outcome
Presence or not of symptoms of temporomandibular joint disorders according to DC/TMD
Time frame: At 3 years follow-up
Pain-intensity (0-10 VAS scale, Von Korf)
Change of maximal unassited jaw opening
Time frame: Baseline and 3 years follow-up
Maximum unassisted jaw opening or interincisal distance (from edge to edge) measured by a Boley gauge. Up 38 in females and up 40 mm in males are considered limited.
5 secondary outcomes
Change of condylar paths angles inclination
Time frame: Baseline and 3-4-years follow-up (end of the study)
Alteration of lateral dental guidance angles
Time frame: Baseline and 4-years follow-up (end of the study)
Change of maximal comfortable jaw opening
Time frame: Baseline and 4-years follow-up (end of the study)
Change of the habitual chewing side
Time frame: Baseline and 3-4-years follow-up (end of the study)
Change of lateral deviation during maximal unassisted jaw opening
Time frame: Baseline, 3 years follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Results publication: PubMed 23593156Santana-Mora U, Lopez-Cedrun J, Mora MJ, Otero XL, Santana-Penin U. Temporomandibular disorders: the habitual chewing side syndrome. PLoS One. 2013 Apr 8;8(4):e59980. doi: 10.1371/journal.pone.0059980. Print 2013.
- Individual participant dataSharing planned: Yes. Data will be shared in a on-line appendix linked from the article in a JCR Journal.
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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.
Urbano Santana-Mora, PhD principal investigator
University of Santiago de Compostela. Spain
Urbano Santana, Prof. study chair
University of Santiago de Compostela. Spain
Mª Jesús Mora principal investigator
University of Santiago de Compostela. Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Joint Disorders and Mastication Disorder, run by University of Santiago de Compostela at 1 site in Spain.
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 4 inclusion and 2 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 1 Oct 2021. 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 Spain. 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?
Presence or not of symptoms of temporomandibular joint disorders according to DC/TMD (time frame: At 3 years follow-up). 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?
On the ClinicalTrials.gov record for NCT03139994, which also lists 1 linked publication.
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 1 Oct 2021.