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

December 5, 2023 updated by: Marmara University
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34736
        • Ecem Ipek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mandibular bone morphometric measurements
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.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

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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