TMJ DisordersWATSNCT03891511
TMJ Fibrocartilage Detection Using MRI
An observational study of TMJ Disorders and MRI Scans, run by Universidad de los Andes, Chile at 1 site in Chile.
Trial summary
Objective: The aims of this study will be to detect the fibrocartilage layer (FC) of the human temporomandibular joint (TMJ) using 3D SPGR (Spoiled GRASS sequence) (T1 WATS) sequence and to compare these results with those of conventional magnetic resonance imaging (DP, T2 MRI) sequences in patients with… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- TMJ Disorders, MRI Scans
- What is being tested?
- MRI scann
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 1 siteChile
- Study dates
- 18 Mar 2019to 30 May 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: participants will be whites, urban, low , medium low and médium socioeconomic level, from Santiago, Chile.
Who may be able to join
- Internal derangement in theTMJ
Who cannot join
- Cardiac pacemaker
- Cochlear implant
- Intracranial vascular clips
- Metal particles in the orbit
- Head or face trauma
- Gout
Show all 12Show fewer
- Generalized osteoarthrosis
- Joint hyperlaxity
- Congenital malformity
- Facial cysts
- Facial tumors
- Previous TMJ surgery
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
San Vicente de Paul Centro de Diagnóstico
Santiago, 750005
Steffi Eckartd, MDS, +562 2943 3900, infoimagen@sanvicentedepaul.cl
Monica Bunster, BA, +562 2943 3900, areacomercial@sanvicentedepaul.cl
About this study
Official title: TMJ Fibrocartilage Detection Using 3D Fat-Suppressed Spoiled Gradient-Echo Magnetic Resonance Imaging
Objective: The aims of this study will be to detect the fibrocartilage layer (FC) of the human temporomandibular joint (TMJ) using 3D SPGR (Spoiled GRASS sequence) (T1 WATS) sequence and to compare these results with those of conventional magnetic resonance imaging (DP, T2 MRI) sequences in patients with temporomandibular disorders (TMD).
Read the detailed description
This prospective and observational study will focused on analyzing morphological characteristics of the fibrocartilage layer of the TMJ based on the MRI scans of 59 patients. All 118 TMJs of these patients will be suitable for analysis, (range: 18-60 years old), females and males affected by TMD and did not undergo previous TMJ treatment.
- Conditions
- TMJ Disorders, MRI Scans
- Being tested
- MRI scann
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scannDevice
Also called T1 WATS
MRI will be performed in the TMJ of participants affected with TMD
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of the TMJ Fibrocartilage layer
The fibrocartilage layer will be evaluated dichotomously (absent/present) Patients will be examined using bilateral MRI (Phillips Intera 1,5 T, Sense Flex S Dual Coil) in the sagittal PD-weighted, T2-weighted and T1-weighted WATS, all in the oblique axis of the mandible condyle and with a closed mouth; dynamic gradient-echo at open mouth at 10 mm, 20 mm and 30 mm of the interincisal distance. Additionally, a coronal PD-weighted sequence with the mouth closed will be performed. Of each TMJ will be taken with 8×8 cm FOV and 0.2 cm spacing. All sequences will carried out using the same equipment and on the same day.
Measured: six months
Discontinuity of the TMJ FC layer
The TMJ fibrocartilage layer will be evaluated dichotomously (continuous/discontinuous).
Measured: six months
Fibrocartilage Signal Intensity
Six regions of interest (ROIs) will be measured in the fibrocartilage layer of each TMJ. (anterior 0°, center 45° and posterior 90°), three in the mandibular condyle and three in the temporal fossa. The fibrocartilage signal intensity in each ROI will be expressed as the mean value of intensity units (Osirix).
All measurements will be made in a simple blinded system by four different observers (ML, MN, CV, GZ) (chi-square test for interobserver agreement: p˂0.05). Measurements will be made separately in the three MRI sequences (length tool, Osirix Imaging software). In all MRI sequences, TMJ will be magnified at a zoom of 3.6. For the T1 WATS sequence, the window width will be set at 90 intensity Units (IU) (all values above +90 Hounsfield Unit (HU) will be white), and the window level was 80 (IU) (all values below +80 HU will be black). All images will be measured and stored in DICOM format., lengt
Measured: six month
Thickness of the TMJ fibrocartilage layer
The TMJ FC thickness will be measured (curve tool, Osirix) and will expressed in millimeters.
Measured: Six months
Length of the TMJ fibrocartilage layer
The lenght of the TMJ FC layer will be measured (curve tool, Osirix) and will expressed in millimeters.
Measured: Six moths
Statistical analysis
The Shapiro-Wilk test and Levene's test will be performed to assess normality of data distribution and homogeneity of variance of the measurements, respectively.
To determine the relationship between the presence or absence of fibrocartilage and the different sequences, Fisher's exact test will be used.
The thickness, length and signal intensity of the fibrocartilage layer will be expressed as a mean value, separated by MRI sequence, and will be analyzed using descriptive statistics.
SPSS v14.0 for Windows, statistical software will be used to perform data analysis.
Measured: seven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start18 Mar 2019
- Primary completion30 Apr 2019 (estimated)
- Study completion30 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for TMJ 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Mayor, University of Chile
- Responsible party
- Principal investigator, Gustavo Moncada, Universidad de los Andes, Chile
- Investigators
- Gustavo Moncada, PhD, Principal investigator, UAndes, Santiago, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891511
- Sponsor's protocol ID
- UM20-08-2
- Acronym
- WATS
- Status last verified
- Mar 2019
- First submitted
- 19 Mar 2019
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD included
Publications
Ren YF, Westesson PL, Isberg A. Magnetic resonance imaging of the temporomandibular joint: value of pseudodynamic images. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 Jan;81(1):110-23. doi: 10.1016/s1079-2104(96)80158-2.
PubMed 8850494Zhang S, Block KT, Frahm J. Magnetic resonance imaging in real time: advances using radial FLASH. J Magn Reson Imaging. 2010 Jan;31(1):101-9. doi: 10.1002/jmri.21987.
PubMed 19938046Gibbs SJ, Simmons HC 3rd. A protocol for magnetic resonance imaging of the temporomandibular joints. Cranio. 1998 Oct;16(4):236-41. doi: 10.1080/08869634.1998.11746063.
PubMed 10029751Brady AP, McDevitt L, Stack JP, Downey D. A technique for magnetic resonance imaging of the temporomandibular joint. Clin Radiol. 1993 Feb;47(2):127-33. doi: 10.1016/s0009-9260(05)81189-4.
PubMed 8435960Eberhard D, Bantleon HP, Steger W. Functional magnetic resonance imaging of temporomandibular joint disorders. Eur J Orthod. 2000 Oct;22(5):489-97. doi: 10.1093/ejo/22.5.489.
PubMed 11105405Disler DG, McCauley TR, Wirth CR, Fuchs MD. Detection of knee hyaline cartilage defects using fat-suppressed three-dimensional spoiled gradient-echo MR imaging: comparison with standard MR imaging and correlation with arthroscopy. AJR Am J Roentgenol. 1995 Aug;165(2):377-82. doi: 10.2214/ajr.165.2.7618561.
PubMed 7618561Disler DG, McCauley TR, Kelman CG, Fuchs MD, Ratner LM, Wirth CR, Hospodar PP. Fat-suppressed three-dimensional spoiled gradient-echo MR imaging of hyaline cartilage defects in the knee: comparison with standard MR imaging and arthroscopy. AJR Am J Roentgenol. 1996 Jul;167(1):127-32. doi: 10.2214/ajr.167.1.8659356.
PubMed 8659356Recht MP, Kramer J, Marcelis S, Pathria MN, Trudell D, Haghighi P, Sartoris DJ, Resnick D. Abnormalities of articular cartilage in the knee: analysis of available MR techniques. Radiology. 1993 May;187(2):473-8. doi: 10.1148/radiology.187.2.8475293.
PubMed 8475293Moncada G, Cortes D, Millas R, Marholz C. Relationship between disk position and degenerative bone changes in temporomandibular joints of young subjects with TMD. An MRI study. J Clin Pediatr Dent. 2014 Spring;38(3):269-76. doi: 10.17796/jcpd.38.3.w43m8474433n7ur2.
PubMed 25095324Dias IM, Coelho PR, Picorelli Assis NM, Pereira Leite FP, Devito KL. Evaluation of the correlation between disc displacements and degenerative bone changes of the temporomandibular joint by means of magnetic resonance images. Int J Oral Maxillofac Surg. 2012 Sep;41(9):1051-7. doi: 10.1016/j.ijom.2012.03.005. Epub 2012 Mar 31.
PubMed 22464851Larheim TA. Role of magnetic resonance imaging in the clinical diagnosis of the temporomandibular joint. Cells Tissues Organs. 2005;180(1):6-21. doi: 10.1159/000086194.
PubMed 16088129Tanaka E, Detamore MS, Mercuri LG. Degenerative disorders of the temporomandibular joint: etiology, diagnosis, and treatment. J Dent Res. 2008 Apr;87(4):296-307. doi: 10.1177/154405910808700406.
PubMed 18362309Stegenga B. Osteoarthritis of the temporomandibular joint organ and its relationship to disc displacement. J Orofac Pain. 2001 Summer;15(3):193-205.
PubMed 11575190Campos MI, Campos PS, Cangussu MC, Guimaraes RC, Line SR. Analysis of magnetic resonance imaging characteristics and pain in temporomandibular joints with and without degenerative changes of the condyle. Int J Oral Maxillofac Surg. 2008 Jun;37(6):529-34. doi: 10.1016/j.ijom.2008.02.011. Epub 2008 Apr 28.
PubMed 18440778Kurita H, Kojima Y, Nakatsuka A, Koike T, Kobayashi H, Kurashina K. Relationship between temporomandibular joint (TMJ)-related pain and morphological changes of the TMJ condyle in patients with temporomandibular disorders. Dentomaxillofac Radiol. 2004 Sep;33(5):329-33. doi: 10.1259/dmfr/13269559.
PubMed 15585811
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TMJ Fibrocartilage Detection Using 3D Fat-Suppressed Spoiled Gradient-Echo Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03891511
- Acronym / sponsor ID
- WATS / UM20-08-2
- Conditions
- TMJ Disorders, MRI Scans
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Collaborators
- Universidad Mayor, University of Chile
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 May 2019 (estimated)
- First posted
- 27 Mar 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.
Objective: The aims of this study will be to detect the fibrocartilage layer (FC) of the human temporomandibular joint (TMJ) using 3D SPGR (Spoiled GRASS sequence) (T1 WATS) sequence and to compare these results with those of conventional magnetic resonance imaging (DP, T2 MRI) sequences in patients with temporomandibular disorders (TMD).
Detailed description
This prospective and observational study will focused on analyzing morphological characteristics of the fibrocartilage layer of the TMJ based on the MRI scans of 59 patients. All 118 TMJs of these patients will be suitable for analysis, (range: 18-60 years old), females and males affected by TMD and did not undergo previous TMJ treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- participants will be whites, urban, low , medium low and médium socioeconomic level, from Santiago, Chile.
Key inclusion criteria (1 listed)
- Internal derangement in theTMJ
Key exclusion criteria (12 listed)
- Cardiac pacemaker
- Cochlear implant
- Intracranial vascular clips
- Metal particles in the orbit
- Head or face trauma
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 |
|---|---|---|
| MRI scannAlso: T1 WATSMRI will be performed in the TMJ of participants affected with TMD | Device | – |
Primary outcome
Presence of the TMJ Fibrocartilage layer
Time frame: six months
The fibrocartilage layer will be evaluated dichotomously (absent/present) Patients will be examined using bilateral MRI (Phillips Intera 1,5 T, Sense Flex S Dual Coil) in the sagittal PD-weighted, T2-weighted and T1-weighted WATS, all in the oblique axis of the mandible condyle and with a closed mouth; dynamic gradient-echo at open mouth at 10 mm, 20 mm and 30 mm of the interincisal distance. Additionally, a coronal PD-weighted sequence with the mouth closed will be performed. Of each TMJ will be taken with 8×8 cm FOV and 0.2 cm spacing. All sequences will carried out using the same equipment and on the same day.
Discontinuity of the TMJ FC layer
Time frame: six months
The TMJ fibrocartilage layer will be evaluated dichotomously (continuous/discontinuous).
Fibrocartilage Signal Intensity
Time frame: six month
Six regions of interest (ROIs) will be measured in the fibrocartilage layer of each TMJ. (anterior 0°, center 45° and posterior 90°), three in the mandibular condyle and three in the temporal fossa. The fibrocartilage signal intensity in each ROI will be expressed as the mean value of intensity units (Osirix). All measurements will be made in a simple blinded system by four different observers (ML, MN, CV, GZ) (chi-square test for interobserver agreement: p˂0.05). Measurements will be made separately in the three MRI sequences (length tool, Osirix Imaging software). In all MRI sequences, TMJ will be magnified at a zoom of 3.6. For the T1 WATS sequence, the window width will be set at 90 intensity Units (IU) (all values above +90 Hounsfield Unit (HU) will be white), and the window level was 80 (IU) (all values below +80 HU will be black). All images will be measured and stored in DICOM format., lengt
Thickness of the TMJ fibrocartilage layer
Time frame: Six months
The TMJ FC thickness will be measured (curve tool, Osirix) and will expressed in millimeters.
Length of the TMJ fibrocartilage layer
Time frame: Six moths
The lenght of the TMJ FC layer will be measured (curve tool, Osirix) and will expressed in millimeters.
Statistical analysis
Time frame: seven months
The Shapiro-Wilk test and Levene's test will be performed to assess normality of data distribution and homogeneity of variance of the measurements, respectively. To determine the relationship between the presence or absence of fibrocartilage and the different sequences, Fisher's exact test will be used. The thickness, length and signal intensity of the fibrocartilage layer will be expressed as a mean value, separated by MRI sequence, and will be analyzed using descriptive statistics. SPSS v14.0 for Windows, statistical software will be used to perform data analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Background: PubMed 8850494Ren YF, Westesson PL, Isberg A. Magnetic resonance imaging of the temporomandibular joint: value of pseudodynamic images. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 Jan;81(1):110-23. doi: 10.1016/s1079-2104(96)80158-2.
- Background: PubMed 19938046Zhang S, Block KT, Frahm J. Magnetic resonance imaging in real time: advances using radial FLASH. J Magn Reson Imaging. 2010 Jan;31(1):101-9. doi: 10.1002/jmri.21987.
- Results publication: PubMed 10029751Gibbs SJ, Simmons HC 3rd. A protocol for magnetic resonance imaging of the temporomandibular joints. Cranio. 1998 Oct;16(4):236-41. doi: 10.1080/08869634.1998.11746063.
- Results publication: PubMed 8435960Brady AP, McDevitt L, Stack JP, Downey D. A technique for magnetic resonance imaging of the temporomandibular joint. Clin Radiol. 1993 Feb;47(2):127-33. doi: 10.1016/s0009-9260(05)81189-4.
- Results publication: PubMed 11105405Eberhard D, Bantleon HP, Steger W. Functional magnetic resonance imaging of temporomandibular joint disorders. Eur J Orthod. 2000 Oct;22(5):489-97. doi: 10.1093/ejo/22.5.489.
- Results publication: PubMed 7618561Disler DG, McCauley TR, Wirth CR, Fuchs MD. Detection of knee hyaline cartilage defects using fat-suppressed three-dimensional spoiled gradient-echo MR imaging: comparison with standard MR imaging and correlation with arthroscopy. AJR Am J Roentgenol. 1995 Aug;165(2):377-82. doi: 10.2214/ajr.165.2.7618561.
- Results publication: PubMed 8659356Disler DG, McCauley TR, Kelman CG, Fuchs MD, Ratner LM, Wirth CR, Hospodar PP. Fat-suppressed three-dimensional spoiled gradient-echo MR imaging of hyaline cartilage defects in the knee: comparison with standard MR imaging and arthroscopy. AJR Am J Roentgenol. 1996 Jul;167(1):127-32. doi: 10.2214/ajr.167.1.8659356.
- Results publication: PubMed 8475293Recht MP, Kramer J, Marcelis S, Pathria MN, Trudell D, Haghighi P, Sartoris DJ, Resnick D. Abnormalities of articular cartilage in the knee: analysis of available MR techniques. Radiology. 1993 May;187(2):473-8. doi: 10.1148/radiology.187.2.8475293.
- Results publication: PubMed 25095324Moncada G, Cortes D, Millas R, Marholz C. Relationship between disk position and degenerative bone changes in temporomandibular joints of young subjects with TMD. An MRI study. J Clin Pediatr Dent. 2014 Spring;38(3):269-76. doi: 10.17796/jcpd.38.3.w43m8474433n7ur2.
- Results publication: PubMed 22464851Dias IM, Coelho PR, Picorelli Assis NM, Pereira Leite FP, Devito KL. Evaluation of the correlation between disc displacements and degenerative bone changes of the temporomandibular joint by means of magnetic resonance images. Int J Oral Maxillofac Surg. 2012 Sep;41(9):1051-7. doi: 10.1016/j.ijom.2012.03.005. Epub 2012 Mar 31.
- Results publication: PubMed 16088129Larheim TA. Role of magnetic resonance imaging in the clinical diagnosis of the temporomandibular joint. Cells Tissues Organs. 2005;180(1):6-21. doi: 10.1159/000086194.
- Results publication: PubMed 18362309Tanaka E, Detamore MS, Mercuri LG. Degenerative disorders of the temporomandibular joint: etiology, diagnosis, and treatment. J Dent Res. 2008 Apr;87(4):296-307. doi: 10.1177/154405910808700406.
- Individual participant dataSharing planned: No. No IPD included
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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.
Gustavo Moncada, PhD principal investigator
UAndes, Santiago, Chile
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 TMJ Disorders and MRI Scans, run by Universidad de los Andes, Chile at 1 site in Chile.
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 12 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: status not confirmed, as of the sponsor's last update on 27 Mar 2019. 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 Chile. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gustavo Moncada, PhD (+56997826334, gmoncada@adsl.tie.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of the TMJ Fibrocartilage layer (time frame: six months). The study lists 6 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 NCT03891511, which also lists 32 linked publications.
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 27 Mar 2019.