Childhood Rheumatic DiseasesNCT05832359
Evaluation of Dental Maturation and Mandibular Bone Morphology in Childhood Rheumatic Diseases
A study testing Panoramic rad. in people with Childhood Rheumatic Diseases, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to examine possible disease-related changes in dental age and mandibular bone morphology in childhood rheumatic diseases. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Rheumatic Diseases
- What is being tested?
- Panoramic rad.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 May 2023to 5 Dec 2023
- Phase
- Interventional
- 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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients aged 6 to 14 years with childhood rheumatism
- Patients without bilateral congenital germ deficiency in the lower teeth
- Patients with seven teeth (except no #8) on the left of the mandibula (No seven teeth on the left of the mandibula, there should be a symmetrical tooth on the right of the mandibula.
Who cannot join
- Patients with bilateral congenital germ deficiency in lower teeth in intraoral and/or radiographic examinations
- Patients with asymmetry and magnification errors and where anatomical structures cannot be seen clearly in the panoramic x-ray
- Patients with a significant number of missing teeth due to trauma or disease, root canal treatment, and pathological tooth structure
- Patients with a history of other chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
The aim of our study is to examine possible disease-related changes in dental age and mandibular bone morphology in childhood rheumatic diseases.
Read the detailed description
to reveal the changes that can occur in different childhood rheumatic diseases, the treatment process of the disease and the drugs used on the dental age and mandible
- Conditions
- Childhood Rheumatic Diseases
- Being tested
- Panoramic rad.
- Keywords
- Childhood rheumatic diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panoramic rad.Radiation
In the study, digital panoramic x-rays of the patients will be evaluated and dental age estimation with Willems method and mandibular bone morphometric measurements will be made.
| Study group | Role | What they receive |
|---|---|---|
| Children diagnosed with childhood rheumatic disease | Experimental | Not described Receives: Radiation: Panoramic rad. |
| Healthy children | Experimental | Not described Receives: Radiation: Panoramic rad. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Age Estimation
The study group will be comprised of newly diagnosed pediatric patients who applied to Umraniye Training and Research Hospital Division of Pediatric Rheumatology and whose treatment is ongoing, and the control group will be composed of pediatric patients without systemic disease who applied to Marmara University Faculty of Dentistry Department of Pedodontics. In the study, digital panoramic x-rays of the patients will be evaluated and dental age estimation with Willems method will be made.
Measured: 3 months
Secondary outcomes (1)
Mandibular bone morphometric measurements
The study group will be comprised of newly diagnosed pediatric patients who applied to Umraniye Training and Research Hospital Division of Pediatric Rheumatology and whose treatment is ongoing, and the control group will be composed of pediatric patients without systemic disease who applied to Marmara University Faculty of Dentistry Department of Pedodontics.For mandibular bone morphometric measurements, fractal analysis, that is a mathematical method describing and analyzing complex shapes and structural patterns such as the bone tissue, will be used in order to assess the bone density, using Image J software. A region of interest will be selected from panoramic radiographs. Image processing will be applied to correct for lightning irregularity, and box-counting method will be used to calculate a fractal dimension.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start19 May 2023
- Primary completion1 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832359
- Sponsor's protocol ID
- MUDHFP10
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dental Maturation and Mandibular Bone Morphology in Childhood Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT05832359
- Acronym / sponsor ID
- MUDHFP10
- Conditions
- Childhood Rheumatic Diseases
- Keywords
- Childhood rheumatic diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 27 Apr 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.
The aim of our study is to examine possible disease-related changes in dental age and mandibular bone morphology in childhood rheumatic diseases.
Detailed description
to reveal the changes that can occur in different childhood rheumatic diseases, the treatment process of the disease and the drugs used on the dental age and mandible
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children diagnosed with childhood rheumatic disease | Experimental | Radiation: Panoramic rad. |
| Healthy children | Experimental | Radiation: Panoramic rad. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients aged 6 to 14 years with childhood rheumatism
- Patients without bilateral congenital germ deficiency in the lower teeth
- Patients with seven teeth (except no #8) on the left of the mandibula (No seven teeth on the left of the mandibula, there should be a symmetrical tooth on the right of the mandibula.
Key exclusion criteria (4 listed)
- Patients with bilateral congenital germ deficiency in lower teeth in intraoral and/or radiographic examinations
- Patients with asymmetry and magnification errors and where anatomical structures cannot be seen clearly in the panoramic x-ray
- Patients with a significant number of missing teeth due to trauma or disease, root canal treatment, and pathological tooth structure
- Patients with a history of other chronic diseases
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 |
|---|---|---|
| Panoramic rad.In the study, digital panoramic x-rays of the patients will be evaluated and dental age estimation with Willems method and mandibular bone morphometric measurements will be made. | Radiation | Children diagnosed with childhood rheumatic disease, Healthy children |
Primary outcome
Dental Age Estimation
Time frame: 3 months
The study group will be comprised of newly diagnosed pediatric patients who applied to Umraniye Training and Research Hospital Division of Pediatric Rheumatology and whose treatment is ongoing, and the control group will be composed of pediatric patients without systemic disease who applied to Marmara University Faculty of Dentistry Department of Pedodontics. In the study, digital panoramic x-rays of the patients will be evaluated and dental age estimation with Willems method will be made.
1 secondary outcome
Mandibular bone morphometric measurements
Time frame: 3 months
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 6 Dec 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panoramic rad. in people with Childhood Rheumatic Diseases, run by Marmara University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 6 Dec 2023. 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 Turkey (Türkiye). 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?
Dental Age Estimation (time frame: 3 months). 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 6 Dec 2023.