Temporomandibular DisorderNCT05680103
Correlation Between Occlussion Types , in Patients With Temporomandibular Disorders.
An observational study of Temporomandibular Disorder, run by Cairo University.
Trial summary
study to find if there is correlation between occlusion types and TMD or not Read more about this study
- Who is it for?
- Ages 16 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- lateral cephalometry
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Feb 2024
- How long will I take part?
- 2 Weeks
- 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 16 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: patients with TMDs and have teeth for dental occlussion
Who may be able to join
- Patients above 16 years old and below 50
- Patients with TMD diagnosed (stage 2 Wilkes classification , anterior disc displacement with reduction, )
- Provided informed consent.
- No history of systemic condition affecting TMJ
- No previous orthodontic ttt
Who cannot join
- Ear diseases.
- History of facial trauma.
- Neurological or oncological disease.
Trial locations and contacts
No sites are listed yet.
Omnia ABD - Elaziz, PhD contact
About this study
Official title: Correlation Between Occlussion Types , in Patients With Temporomandibular Disorders. : A Cross Sectional Study
study to find if there is correlation between occlusion types and TMD or not
Read the detailed description
The relationship among occlusion, condylar position and temporomandibular disorders (TMDs) has been part of an extensive discussion in the dental field. There is a strong belief that the discrepancy between the centric relation (CR) and the intercuspal position (ICP) could predispose to the presence of TMDs . It was suggested in the past in the earlier studies that TMD is more common among the individuals who have Angle class II and class III , malocclusion , open bite , and cross bite . In the 1990s, studies suggested that some occlusal and skeletal characteristics as anterior open bite, unilateral posterior crossbite, overjet greater than 6-7mm, absence of five or more posterior teeth and CR to maximum intercuspation (MI) discrepancy greater than 2mm could be considered occlusal risk factors for TMDs . In their study, Oyetola et al. reported that 25% of the evaluated TMD patients had malocclusion Yet, recently with studies and systematic reviews , this idea ( alocclusion is the main cause of TMD) started to lose its support, and many studies showed that sensitivity to nociceptive stimulations and psychological factors are of more importance in the etiology of TMD
- Conditions
- Temporomandibular Disorder
- Being tested
- lateral cephalometry
- 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.
lateral cephalometryRadiation
lateral x-ray beam to capture lateral cephalometry of patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ADDwR in patients with class III malocclusion
lateral cephalometry will be taken for patients with TMDs and then measurements will be done to calculate SNA and SNB to see Prevalence of ADDwR in patients with class III malocclusion
Measured: baseline
Secondary outcomes (1)
Prevalence of ADDwR in patients with class I and class II malocclusion
lateral cephalometry will be taken for patients with TMDs and then measurements will be done to calculate SNA and SNB to see Prevalence of ADDwR in patients with class I and class II malocclusion
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study startMar 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- 200 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Armia Zaki, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680103
- Sponsor's protocol ID
- occlussion and TMDs
- Status last verified
- Feb 2023
- First submitted
- 25 Dec 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maizlin ZV, Nutiu N, Dent PB, Vos PM, Fenton DM, Kirby JM, Vora P, Gillies JH, Clement JJ. Displacement of the temporomandibular joint disk: correlation between clinical findings and MRI characteristics. J Can Dent Assoc. 2010;76:a3.
PubMed 20633336Cai XY, Jin JM, Yang C. Changes in disc position, disc length, and condylar height in the temporomandibular joint with anterior disc displacement: a longitudinal retrospective magnetic resonance imaging study. J Oral Maxillofac Surg. 2011 Nov;69(11):e340-6. doi: 10.1016/j.joms.2011.02.038. Epub 2011 Jul 1.
PubMed 21723023
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Occlussion Types , in Patients With Temporomandibular Disorders. : A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05680103
- Acronym / sponsor ID
- occlussion and TMDs
- Conditions
- Temporomandibular Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 11 Jan 2023 (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.
study to find if there is correlation between occlusion types and TMD or not
Detailed description
The relationship among occlusion, condylar position and temporomandibular disorders (TMDs) has been part of an extensive discussion in the dental field. There is a strong belief that the discrepancy between the centric relation (CR) and the intercuspal position (ICP) could predispose to the presence of TMDs . It was suggested in the past in the earlier studies that TMD is more common among the individuals who have Angle class II and class III , malocclusion , open bite , and cross bite . In the 1990s, studies suggested that some occlusal and skeletal characteristics as anterior open bite, unilateral posterior crossbite, overjet greater than 6-7mm, absence of five or more posterior teeth and CR to maximum intercuspation (MI) discrepancy greater than 2mm could be considered occlusal risk factors for TMDs . In their study, Oyetola et al. reported that 25% of the evaluated TMD patients had malocclusion Yet, recently with studies and systematic reviews , this idea ( alocclusion is the main cause of TMD) started to lose its support, and many studies showed that sensitivity to nociceptive stimulations and psychological factors are of more importance in the etiology of TMD
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- patients with TMDs and have teeth for dental occlussion
Key inclusion criteria (5 listed)
- Patients above 16 years old and below 50
- Patients with TMD diagnosed (stage 2 Wilkes classification , anterior disc displacement with reduction, )
- Provided informed consent.
- No history of systemic condition affecting TMJ
- No previous orthodontic ttt
Key exclusion criteria (3 listed)
- Ear diseases.
- History of facial trauma.
- Neurological or oncological disease.
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 |
|---|---|---|
| lateral cephalometrylateral x-ray beam to capture lateral cephalometry of patients | Radiation | – |
Primary outcome
Prevalence of ADDwR in patients with class III malocclusion
Time frame: baseline
lateral cephalometry will be taken for patients with TMDs and then measurements will be done to calculate SNA and SNB to see Prevalence of ADDwR in patients with class III malocclusion
1 secondary outcome
Prevalence of ADDwR in patients with class I and class II malocclusion
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 20633336Maizlin ZV, Nutiu N, Dent PB, Vos PM, Fenton DM, Kirby JM, Vora P, Gillies JH, Clement JJ. Displacement of the temporomandibular joint disk: correlation between clinical findings and MRI characteristics. J Can Dent Assoc. 2010;76:a3.
- Background: PubMed 21723023Cai XY, Jin JM, Yang C. Changes in disc position, disc length, and condylar height in the temporomandibular joint with anterior disc displacement: a longitudinal retrospective magnetic resonance imaging study. J Oral Maxillofac Surg. 2011 Nov;69(11):e340-6. doi: 10.1016/j.joms.2011.02.038. Epub 2011 Jul 1.
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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.
Omnia ABD - Elaziz, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorder, run by Cairo University.
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 5 inclusion and 3 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 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Mina Habib, Bds (+201207337835, mina_armia@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of ADDwR in patients with class III malocclusion (time frame: baseline). 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 NCT05680103, which also lists 2 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 1 Mar 2023.