Temporomandibular Joint DisordersNCT05637372
Relationships Between Anterior and Condylar Guidance - Comparison by CBCT and Electronic Axiography
An observational study of Temporomandibular Joint Disorders and Occlusion, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The aim of the following study was to investigate the existence of a statistically significant correlation between the incisal features (incisal guidance angle, interincisal angle, overbite, overjet), temporomandibular joint (TMJ) morphology and its function. The hypothesis was: I. Read more about this study
- Who is it for?
- Ages 20 to 24 years
- Conditions the study is for
- Temporomandibular Joint Disorders, Occlusion
- What is being tested?
- CBCT
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 20 Jul 2022to 20 Oct 2022
- 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 20 to 24 years
- All sexes
- Adult
Study population: primary care clinic
Who may be able to join
- 20-24 years old
Who cannot join
- history of trauma, orthodontic treatment or temporomandibular disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complicated Relationships Between Anterior and Condylar Guidance and Their Clinical Implications- Comparison by Cone Beam Computed Tomography and Electronic Axiography - an Observational Cohort Cross-sectional Study.
The aim of the following study was to investigate the existence of a statistically significant correlation between the incisal features (incisal guidance angle, interincisal angle, overbite, overjet), temporomandibular joint (TMJ) morphology and its function. The hypothesis was:
- The protrusive movement of the mandible does correlate with the TMJ anatomy. II. The protrusive movement of the mandible does not correlate with the incisal features.
III. The position and relationship of upper and lower permanent incisors do not have a direct and significant effect on the TMJ morphology in young adults.
Read the detailed description
The study was based on anatomical and functional measurements of the parameters within the masticatory system. The study group was composed in a way that all the participants (age 20-24) had the temporomandibular joints fully developed and at the same time not yet modified by adaptive processes.
- Conditions
- Temporomandibular Joint Disorders, Occlusion
- Being tested
- CBCT
- Medical subject headings
- Temporomandibular Joint Disorders, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCTRadiation
CBCT scan
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients without any disorders and diseases in age range ensuring full temporomandibular joint development. Receives: Radiation: CBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sagittal condylar guidance angle during protrusion
recorded with axiograph
Measured: evaluated within 24h from baseline visit
Vertical height of the temporomandibular joint fossa
measured on Cone Beam Computed Tomography
Measured: evaluated within 24h from baseline visit
Sagittal condylar guidance angle on Cone Beam Computed Tomography
conducted in 4 variants of measurements
Measured: evaluated within 24h from baseline visit
Features of the incisors
incisal guidance angle, interincisal angle, overjet, overbite measured on Cone Beam Computed Tomography
Measured: evaluated within 24h from baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start20 Jul 2022
- Primary completion19 Aug 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agata Żółtowska, Medical University of Gdansk
- Investigators
- Łukasz Lassmann, DDS, Study director, Dental Sense Medicover, 80-283 Gdańsk, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637372
- Sponsor's protocol ID
- NKBBN/1043/2021-2022-SCGA
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prasad KD, Shah N, Hegde C. A clinico-radiographic analysis of sagittal condylar guidance determined by protrusive interocclusal registration and panoramic radiographic images in humans. Contemp Clin Dent. 2012 Oct;3(4):383-7. doi: 10.4103/0976-237X.107419.
PubMed 23633793Shreshta P, Jain V, Bhalla A, Pruthi G. A comparative study to measure the condylar guidance by the radiographic and clinical methods. J Adv Prosthodont. 2012 Aug;4(3):153-7. doi: 10.4047/jap.2012.4.3.153. Epub 2012 Aug 28.
PubMed 22977723Dawson PE. Determining the determinants of occlusion. Int J Periodontics Restorative Dent. 1983;3(6):8-21. No abstract available.
PubMed 6584415Han S, Shin SM, Choi YS, Kim SY, Ko CC, Kim YI. Morphometric analysis for evaluating the relation between incisal guidance angle, occlusal plane angle, and functional temporomandibular joint shape variation. Acta Odontol Scand. 2018 May;76(4):287-293. doi: 10.1080/00016357.2017.1420227. Epub 2018 Jan 11.
PubMed 29322857Luca, L.; Manfredini, D.; Arveda, N.; Rossi, L.; Siciliani, G. A Cone-Beam Computerized Tomography Assessment of the Relationship between Upper Incisors Inclination and Articular Eminence Features in Orthodontically Untreated Patients with Different Facial Type. J World Fed Orthod 2016, 5 (2), 56-63. https://doi.org/10.1016/j.ejwf.2016.05.001
Manfredini D, Lombardo L, Siciliani G. Temporomandibular disorders and dental occlusion. A systematic review of association studies: end of an era? J Oral Rehabil. 2017 Nov;44(11):908-923. doi: 10.1111/joor.12531. Epub 2017 Jul 2.
PubMed 28600812
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complicated Relationships Between Anterior and Condylar Guidance and Their Clinical Implications- Comparison by Cone Beam Computed Tomography and Electronic Axiography - an Observational Cohort Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT05637372
- Acronym / sponsor ID
- NKBBN/1043/2021-2022-SCGA
- Conditions
- Temporomandibular Joint Disorders, Occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 5 Dec 2022 (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 aim of the following study was to investigate the existence of a statistically significant correlation between the incisal features (incisal guidance angle, interincisal angle, overbite, overjet), temporomandibular joint (TMJ) morphology and its function. The hypothesis was:
- The protrusive movement of the mandible does correlate with the TMJ anatomy. II. The protrusive movement of the mandible does not correlate with the incisal features.
III. The position and relationship of upper and lower permanent incisors do not have a direct and significant effect on the TMJ morphology in young adults.
Detailed description
The study was based on anatomical and functional measurements of the parameters within the masticatory system. The study group was composed in a way that all the participants (age 20-24) had the temporomandibular joints fully developed and at the same time not yet modified by adaptive processes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Radiation: CBCTPatients without any disorders and diseases in age range ensuring full temporomandibular joint development. |
Who may qualify
- Ages
- 20 to 24 years
- Sex
- All
- Age groups
- Adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- 20-24 years old
Key exclusion criteria (1 listed)
- history of trauma, orthodontic treatment or temporomandibular disorders
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 |
|---|---|---|
| CBCTCBCT scan | Radiation | Study group |
Primary outcome
Sagittal condylar guidance angle during protrusion
Time frame: evaluated within 24h from baseline visit
recorded with axiograph
Vertical height of the temporomandibular joint fossa
Time frame: evaluated within 24h from baseline visit
measured on Cone Beam Computed Tomography
Sagittal condylar guidance angle on Cone Beam Computed Tomography
Time frame: evaluated within 24h from baseline visit
conducted in 4 variants of measurements
Features of the incisors
Time frame: evaluated within 24h from baseline visit
incisal guidance angle, interincisal angle, overjet, overbite measured on Cone Beam Computed Tomography
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 5 Dec 2022.
- Background: PubMed 23633793Prasad KD, Shah N, Hegde C. A clinico-radiographic analysis of sagittal condylar guidance determined by protrusive interocclusal registration and panoramic radiographic images in humans. Contemp Clin Dent. 2012 Oct;3(4):383-7. doi: 10.4103/0976-237X.107419.
- Background: PubMed 22977723Shreshta P, Jain V, Bhalla A, Pruthi G. A comparative study to measure the condylar guidance by the radiographic and clinical methods. J Adv Prosthodont. 2012 Aug;4(3):153-7. doi: 10.4047/jap.2012.4.3.153. Epub 2012 Aug 28.
- Background: PubMed 6584415Dawson PE. Determining the determinants of occlusion. Int J Periodontics Restorative Dent. 1983;3(6):8-21. No abstract available.
- Background: PubMed 29322857Han S, Shin SM, Choi YS, Kim SY, Ko CC, Kim YI. Morphometric analysis for evaluating the relation between incisal guidance angle, occlusal plane angle, and functional temporomandibular joint shape variation. Acta Odontol Scand. 2018 May;76(4):287-293. doi: 10.1080/00016357.2017.1420227. Epub 2018 Jan 11.
- BackgroundLuca, L.; Manfredini, D.; Arveda, N.; Rossi, L.; Siciliani, G. A Cone-Beam Computerized Tomography Assessment of the Relationship between Upper Incisors Inclination and Articular Eminence Features in Orthodontically Untreated Patients with Different Facial Type. J World Fed Orthod 2016, 5 (2), 56-63. https://doi.org/10.1016/j.ejwf.2016.05.001
- Background: PubMed 28600812Manfredini D, Lombardo L, Siciliani G. Temporomandibular disorders and dental occlusion. A systematic review of association studies: end of an era? J Oral Rehabil. 2017 Nov;44(11):908-923. doi: 10.1111/joor.12531. Epub 2017 Jul 2.
- Individual participant dataSharing planned: No
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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.
Łukasz Lassmann, DDS study director
Dental Sense Medicover, 80-283 Gdańsk, Poland
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 Occlusion, run by Medical University of Gdansk at 1 site in Poland.
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 5 Dec 2022. 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 Poland. 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?
Sagittal condylar guidance angle during protrusion (time frame: evaluated within 24h from baseline visit). The study lists 4 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 NCT05637372, which also lists 6 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 5 Dec 2022.