TMJ DisorderNCT04543981
Prevalence of the Signs and Symptoms of TMD in Adolescents
An observational study of TMJ Disorder and TMD, run by Cairo University at 1 site in Egypt.
Trial summary
the Prevalence of the Signs and Symptoms of Tempro-mandibular Joint Disorder in a sample of Egyptian adolescents Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- TMJ Disorder, TMD
- What is being tested?
- Diagnostic Criteria for Tempro-mandibular Disorders(DC/TMD)
- How many people
- 733 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to Jul 2021
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: DC/TMD shhts will be assessed and obtained from adolescents in Diagnostic center clinic at the faculty of Dentistry, Cairo University
Who may be able to join
- Adolescents(age range10-18 years old).
- A well-defined dentalCl I, Cl II/1, Cl II/2, and Cl III relationship (Angle Classification).
- Mixed and permanent dentition.
- Both sexes.
- Normal skeletal pattern
Who cannot join
- Adolescents with syndromes.
- Systemic diseases affecting bones.
- Adolescents with rheumatoid arthritis.
- Previous trauma in the face.
- Neurological disorders.
- Psychiatric disorders.
- Neoplasia.
- Adolescents who had received orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, Cairo/Giza, 12511
Manal foda, professor, 01006606864, manalyehia-3@hotmail.com
About this study
Official title: Prevalence of the Signs and Symptoms of Tempro-mandibular Joint Disorder in a Sample of Egyptian Adolescents According to Diagnostic Criteria for Tempro-mandibular Disorders(DC/TMD):A Cross Sectional Study
the Prevalence of the Signs and Symptoms of Tempro-mandibular Joint Disorder in a sample of Egyptian adolescents
Read the detailed description
Our study is observational cross sectional study to evaluate the prevalence ofTempro-mandibular Joint Disorder( TMDs) in Egyptian adolescents based on Diagnostic Criteria for Tempro-mandibular Disorders(DC/TMD) .The following examinationwill be done for each patient and recorded in his/her chart:
Include maximal mandibular opening capacity, joint noises, deviation of mandible during opening and closing, tenderness of the TMJ and masticatory muscles, headache and pain in TMJ area.
All clinical examinations will be carried out by one investigator. Examination of TMJ disorders include the following aspects: I) Examination of TMJ sounds (clicking and crepitus) using a stethoscope over the TMJ area and by having the patient open and close the mouth.
II) Associated muscle disorders will be determined by:
- palpation of TMJ area.
- digital palpation and functional manipulation of the masticatory muscles according to Okeson.
- Conditions
- TMJ Disorder, TMD
- Being tested
- Diagnostic Criteria for Tempro-mandibular Disorders(DC/TMD)
- 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.
Diagnostic Criteria for Tempro-mandibular Disorders(DC/TMD)Diagnostic test
diagnostic sheet include questions to be answered by the patients and others include examinations will be done by the investigator
What is being measured
The primary outcome is the main question the study is designed to answer.
TMD
adolescents diagnosed positively for any TMD subtype (overall TMD) by DC/TMD.
Measured: at the time of examination of each participant
Secondary outcomes (3)
Myofacial pain
pain in each muscle of mastication will be recorded
Measured: at the time of examination of each participant
mouth opening
limitation of mouth opening and pain during such movement
Measured: at the time of examination of each participant
TMJ noises
Clicking and crepitus in tempro-mandibular joint
Measured: at the time of examination of each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Jul 2020
- Primary completion1 Jun 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ 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
- 733 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelrahman Abdelaleem, Cairo University
- Investigators
- Manal foda, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543981
- Sponsor's protocol ID
- ORTH 1-1-1
- Status last verified
- Sep 2020
- First submitted
- 3 Sep 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of the Signs and Symptoms of Tempro-mandibular Joint Disorder in a Sample of Egyptian Adolescents According to Diagnostic Criteria for Tempro-mandibular Disorders(DC/TMD):A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04543981
- Acronym / sponsor ID
- ORTH 1-1-1
- Conditions
- TMJ Disorder, TMD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 733 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 10 Sep 2020 (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 Prevalence of the Signs and Symptoms of Tempro-mandibular Joint Disorder in a sample of Egyptian adolescents
Detailed description
Our study is observational cross sectional study to evaluate the prevalence ofTempro-mandibular Joint Disorder( TMDs) in Egyptian adolescents based on Diagnostic Criteria for Tempro-mandibular Disorders(DC/TMD) .The following examinationwill be done for each patient and recorded in his/her chart:
Include maximal mandibular opening capacity, joint noises, deviation of mandible during opening and closing, tenderness of the TMJ and masticatory muscles, headache and pain in TMJ area.
All clinical examinations will be carried out by one investigator. Examination of TMJ disorders include the following aspects: I) Examination of TMJ sounds (clicking and crepitus) using a stethoscope over the TMJ area and by having the patient open and close the mouth.
II) Associated muscle disorders will be determined by:
- palpation of TMJ area.
- digital palpation and functional manipulation of the masticatory muscles according to Okeson.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- DC/TMD shhts will be assessed and obtained from adolescents in Diagnostic center clinic at the faculty of Dentistry, Cairo University
Key inclusion criteria (5 listed)
- Adolescents(age range10-18 years old).
- A well-defined dentalCl I, Cl II/1, Cl II/2, and Cl III relationship (Angle Classification).
- Mixed and permanent dentition.
- Both sexes.
- Normal skeletal pattern
Key exclusion criteria (8 listed)
- Adolescents with syndromes.
- Systemic diseases affecting bones.
- Adolescents with rheumatoid arthritis.
- Previous trauma in the face.
- Neurological 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 |
|---|---|---|
| Diagnostic Criteria for Tempro-mandibular Disorders(DC/TMD)diagnostic sheet include questions to be answered by the patients and others include examinations will be done by the investigator | Diagnostic test | – |
Primary outcome
TMD
Time frame: at the time of examination of each participant
adolescents diagnosed positively for any TMD subtype (overall TMD) by DC/TMD.
3 secondary outcomes
Myofacial pain
Time frame: at the time of examination of each participant
mouth opening
Time frame: at the time of examination of each participant
TMJ noises
Time frame: at the time of examination of each participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Manal foda, professor study director
Cairo University
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 Disorder and TMD, run by Cairo University at 1 site in Egypt.
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 8 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 10 Sep 2020. 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 Egypt. 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 Mohamed Abdelaleem (01005246200 ext. +2, mohamed.abdelaleem@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TMD (time frame: at the time of examination of each participant). 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 10 Sep 2020.