NCT04608526

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 20, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

October 20, 2020

Last Update Submit

October 28, 2020

Conditions

Keywords

Disturbances in dental developmentfractal analysispediatric patientsradiology

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Group 1

Patients without deep dentin caries / apical rarefying osteitis

Diagnostic Test: Fractal analysis

Group 2

Patients with deep dentin caries / apical rarefying osteitis on the right or left sides

Diagnostic Test: Fractal analysis

Group 3

Patients with deep dentin caries / apical rarefying osteitis on either the right and left side

Diagnostic Test: Fractal analysis

Interventions

Fractal analysisDIAGNOSTIC_TEST

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.

Group 1Group 2Group 3

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

* systemically healthy, * 8-13 years-old, * applied to the Clinic between January 2018 and April 2020 patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sema Aydinoğlu

Rize, Turkey (Türkiye)

Location

Study Officials

  • SEMA AYDINOĞLU

    Recep Tayyip Erdogan University Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 20, 2020

First Posted

October 29, 2020

Study Start

June 1, 2020

Primary Completion

September 1, 2020

Study Completion

October 19, 2020

Last Updated

October 29, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations