Dental Caries in ChildrenNCT04608526
Relationship Between Tooth Decay and Trabecular Bone
An observational study of Dental Caries in Children and Pediatric Patients, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children, Pediatric Patients, Radiology
- What is being tested?
- Fractal analysis
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 19 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: * systemically healthy, * 8-13 years-old, * applied to the Clinic between January 2018 and April 2020 patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Relationship Between Tooth Decay and Trabecular Bone Structure in Pediatric Patients by Fractal Analysis Method: A Retrospective Study
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.
- Conditions
- Dental Caries in Children, Pediatric Patients, Radiology
- Being tested
- Fractal analysis
- Keywords
- Disturbances in dental development, fractal analysis, pediatric patients, radiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients without deep dentin caries / apical rarefying osteitis Receives: Diagnostic Test: Fractal analysis | |
| Group 2 | Patients with deep dentin caries / apical rarefying osteitis on the right or left sides Receives: Diagnostic Test: Fractal analysis | |
| Group 3 | Patients with deep dentin caries / apical rarefying osteitis on either the right and left side Receives: Diagnostic Test: Fractal analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: for two months from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 Jun 2020
- Primary completion1 Sep 2020
- Study completion19 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sema Aydınoglu, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- SEMA AYDINOĞLU, Study director, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608526
- Sponsor's protocol ID
- 2020/127
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Tooth Decay and Trabecular Bone Structure in Pediatric Patients by Fractal Analysis Method: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04608526
- Acronym / sponsor ID
- 2020/127
- Conditions
- Dental Caries in Children, Pediatric Patients, Radiology
- Keywords
- Disturbances in dental development, fractal analysis, pediatric patients, radiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 19 Oct 2020 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Fractal analysisPatients without deep dentin caries / apical rarefying osteitis |
| Group 2 | – | Diagnostic Test: Fractal analysisPatients with deep dentin caries / apical rarefying osteitis on the right or left sides |
| Group 3 | – | Diagnostic Test: Fractal analysisPatients with deep dentin caries / apical rarefying osteitis on either the right and left side |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- * systemically healthy, * 8-13 years-old, * applied to the Clinic between January 2018 and April 2020 patients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractal analysisFractal 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. | Diagnostic test | Group 1, Group 2, Group 3 |
Primary outcome
The effects of dental caries on the jawbone in children aged between 8-13 years
Time frame: for two months from the beginning of the study
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEMA AYDINOĞLU study director
Recep Tayyip Erdogan University Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries in Children and Pediatric Patients, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of dental caries on the jawbone in children aged between 8-13 years (time frame: for two months from the beginning of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.