Back to resultsEvaluation of Dental Maturation and Mandibular Bone Morphology in Childhood Rheumatic Diseases
Primary Purpose
Childhood Rheumatic Diseases
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Panoramic rad.
Sponsored by
About this trial
This is an interventional screening trial for Childhood Rheumatic Diseases focused on measuring Childhood rheumatic diseases
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Sites / Locations
- Ecem Ipek
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Children diagnosed with childhood rheumatic disease
Healthy children
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05832359
Brief Title
Evaluation of Dental Maturation and Mandibular Bone Morphology in Childhood Rheumatic Diseases
Official Title
Evaluation of Dental Maturation and Mandibular Bone Morphology in Childhood Rheumatic Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 19, 2023 (Anticipated)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
June 14, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Rheumatic Diseases
Keywords
Childhood rheumatic diseases
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
278 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Children diagnosed with childhood rheumatic disease
Arm Type
Experimental
Arm Title
Healthy children
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Panoramic rad.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dental Age Estimation
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mandibular bone morphometric measurements
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Female/Male
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ecem Ipek
Phone
05394235058
Email
ecmipek@hotmail.com
Facility Information:
Facility Name
Ecem Ipek
City
Istanbul
ZIP/Postal Code
34736
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ecem Ipek
Phone
05394235058
Email
ecmipek@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Dental Maturation and Mandibular Bone Morphology in Childhood Rheumatic Diseases
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