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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04608526
Other study ID # 2020/127
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date October 19, 2020

Study information

Verified date October 2020
Source Recep Tayyip Erdogan University Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Chewing, a movement that matures with experiences, has effects on the growth and development of the stomatognathic system. Tooth decay, which is known to have effects on chewing, can affect the jaw bone due to its indirect effect on the mechanical forces transmitted to the jaw bone. This study was aimed to evaluate the relationship between dental caries and jaw bone trabeculation during the growth and development processes in children by fractal dimension analysis method. 40 patients with deep-dentin caries / apical rarefying osteitis on the right or left side, 40 patients with deep-dentin caries / apical rarefying osteitis on either the right and left sides and 40 patients without deep-dentin caries / apical rarefying osteitis between 8-13 ages were randomly selected. Digital panoramic images of the selected patients were analyzed with fractal dimension analysis.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date October 19, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 13 Years
Eligibility Inclusion Criteria: - Panoramic radiographs of systemically healthy 8-13 years-old patients, - Who applied to the Clinic between January 2018 and April 2020 were retrospectively scanned. - Patients with 1st molars whose root development was completed and the 2nd molars not erupted yet were included. Exclusion Criteria: - Patients with temporomandibular joint disorders, any systemic disease, exposed to trauma in the area to be measured, received orthodontic treatment for the last 2 years or had an ongoing orthodontic treatment, unilateral / bilateral cross-bite and had parafunctional habits in their anamnesis were excluded.

Study Design


Intervention

Diagnostic Test:
Fractal analysis
Fractal dimension (FD) analysis, which can be measured in panoramic radiographs, is a technique that can be used to measure mandibular trabecular architecture and to determine early periodontal changes in alveolar bone. Fractal analysis method, which has become more and more popular in recent years; has features such as being easily accessible, not being affected by variables such as projection geometry and radiological density and providing objective data about trabecular structures. It can be measured in the patients' existing panoramic images and does not require extra imaging and material.

Locations

Country Name City State
Turkey Sema Aydinoglu Rize

Sponsors (1)

Lead Sponsor Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The effects of dental caries on the jawbone in children aged between 8-13 years Digital panoramic radiographs of the patients included in the study were recorded in high resolution TIF (tagged image file) format to ensure standardization of the images and adjusted to 2836 x 1500 pixels. ImageJ version 1.53a, and bundled with 64-bit Java for Windows (National Institutes of Health, Bethesda) were used for fractal analysis of the images.
Fractal analysis on digital panoramic radiographs transferred to ImageJ (National Institutes of Health, Bethesda) program, 3 ROI (region of interest) areas of 15x15 pixels were determined for each patient with condyle, antegonial notch in the right and left hemimandible and in the center of the ramus.The number of frames containing the trabecular structure and the total number of frames were calculated for different dimensions. The values were transferred to the logarithmic scale and the slope of the curve fitting the points on the graph gave the result of the fractal measurement.
for two months from the beginning of the study
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