Evaluation of Dental Maturation and Mandibular Bone Morphology in Childhood Rheumatic Diseases

The aim of our study is to examine possible disease-related changes in dental age and mandibular bone morphology in childhood rheumatic diseases.

Study Overview

• Status: Completed
• Conditions: Childhood Rheumatic Diseases
• Intervention / Treatment: Radiation: Panoramic rad.

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 Type: Interventional
• Enrollment (Actual): 278
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34736
    • Ecem Ipek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy children	Radiation: 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.
Experimental: Children diagnosed with childhood rheumatic disease	Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Childhood rheumatic diseases
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: MUDHFP10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No