PeriodontitisPBFMNCT07209579
Fractal and Morphometric Analysis of Mandibular Bone in Periodontitis
An observational study of Periodontitis and Panoramic Radiography, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This retrospective study aims to evaluate the differences in mandibular bone structure between individuals with periodontitis and healthy controls using panoramic radiographs. Fractal analysis and radiomorphometric indices, such as the mental index (MI) and panoramic mandibular index (PMI), will be applied to assess… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Panoramic Radiography
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 15 May 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consisted of adults aged 18 years and older who underwent panoramic radiographic examinations at the Department of Oral and Maxillofacial Radiology, Istanbul University. The case group included patients diagnosed with periodontitis based on clinical and radiographic criteria, while the control group included periodontally and systemically healthy individuals.
Who may be able to join
- Individuals aged 18 or older
- Patients with clinically and radiographically diagnosed periodontitis (case group)
- Periodontally and systemically healthy individuals (control group)
Who cannot join
- Individuals younger than 18
- Patients with systemic or syndromic conditions affecting bone structure
- Panoramic radiographs with artifacts or diagnostic errors
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Faculty of Dentistry
Istanbul
About this study
Official title: Evaluation of Mandibular Bone Structure Differences Between Individuals With Periodontitis and Healthy Individuals on Panoramic Radiographs Using Fractal and Morphometric Analyses: A Retrospective Study
This retrospective study aims to evaluate the differences in mandibular bone structure between individuals with periodontitis and healthy controls using panoramic radiographs. Fractal analysis and radiomorphometric indices, such as the mental index (MI) and panoramic mandibular index (PMI), will be applied to assess trabecular and cortical bone. The study population includes patients previously diagnosed and treated for periodontitis and healthy individuals with available panoramic radiographs. By comparing bone quality and microarchitecture between the groups, the study seeks to determine the diagnostic value of panoramic radiographs for detecting periodontal bone changes and to provide insights for early diagnosis and treatment planning in dental practice.
Read the detailed description
Periodontitis is a common inflammatory disease characterized by the destruction of tooth-supporting tissues, often caused by specific microorganisms. In addition to clinical evaluation, radiographic assessment of alveolar bone loss is essential for the diagnosis, treatment planning, and prognosis of periodontal diseases. Panoramic radiography is widely used in oral and maxillofacial imaging and can provide valuable information about cortical and trabecular bone structures through quantitative methods.
Fractal analysis is a mathematical approach that measures the complexity and trabecular patterns of bone. It has been shown to be independent of projection geometry and is commonly applied in digital radiographs. The fractal dimension (FD) reflects the degree of trabecular complexity and can serve as a numerical indicator of bone microarchitecture. The box-counting method, as described by White and Rudolph, will be employed in this study using ImageJ software. In addition to fractal analysis, morphometric indices such as the mental index (MI) and panoramic mandibular index (PMI) will be calculated to assess mandibular cortical thickness and morphology.
This retrospective observational study will include 120 panoramic radiographs obtained from the archives of the Department of Oral and Maxillofacial Radiology, Istanbul University Faculty of Dentistry. The study group will consist of patients with a confirmed diagnosis of periodontitis according to the 2017 classification by the European Federation of Periodontology and the American Academy of Periodontology, while the control group will include systemically healthy individuals with no periodontal disease. Exclusion criteria include individuals under 18 years of age, those with systemic or syndromic conditions, and radiographs with diagnostic errors.
Radiographic measurements will be performed independently by two oral and maxillofacial radiologists, and intra- and inter-observer agreement will be tested through repeated evaluations. Statistical analyses will be conducted using NCSS 2007 software, applying descriptive statistics, Shapiro-Wilk test for normality, independent t-test or Mann-Whitney U test for group comparisons, and chi-square tests for categorical data, with a significance level of p<0.05.
The study is expected to reveal quantitative differences in mandibular bone structure between individuals with periodontitis and healthy controls. The results may contribute to improved diagnostic accuracy of panoramic radiographs in periodontal disease and provide additional tools for early detection and risk assessment in clinical practice.
- Conditions
- Periodontitis, Panoramic Radiography
- Keywords
- Fractal analysis, Morphometric indices, Panoramic radiography, Mandibular bone, Periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis Group | Individuals diagnosed with periodontitis based on 2017 EFP/AAP classification | |
| Healthy Control Group | Systemically and periodontally healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in fractal dimension values between periodontitis and healthy groups
Fractal dimension (FD) values of mandibular bone will be measured from panoramic radiographs using ImageJ software and compared between periodontitis patients and healthy controls.
Measured: At baseline
Secondary outcomes (1)
Differences in morphometric indices between groups
Morphometric indices will be calculated and compared between periodontitis patients and healthy controls.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start15 Apr 2023
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sedef Ayşe Taşyapan, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209579
- Sponsor's protocol ID
- 1717821
- Acronym
- PBFM
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- 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 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mandibular Bone Structure Differences Between Individuals With Periodontitis and Healthy Individuals on Panoramic Radiographs Using Fractal and Morphometric Analyses: A Retrospective Study
- ClinicalTrials.gov ID
- NCT07209579
- Acronym / sponsor ID
- PBFM / 1717821
- Conditions
- Periodontitis, Panoramic Radiography
- Keywords
- Fractal analysis, Morphometric indices, Panoramic radiography, Mandibular bone, Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 7 Oct 2025 (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.
This retrospective study aims to evaluate the differences in mandibular bone structure between individuals with periodontitis and healthy controls using panoramic radiographs. Fractal analysis and radiomorphometric indices, such as the mental index (MI) and panoramic mandibular index (PMI), will be applied to assess trabecular and cortical bone. The study population includes patients previously diagnosed and treated for periodontitis and healthy individuals with available panoramic radiographs. By comparing bone quality and microarchitecture between the groups, the study seeks to determine the diagnostic value of panoramic radiographs for detecting periodontal bone changes and to provide insights for early diagnosis and treatment planning in dental practice.
Detailed description
Periodontitis is a common inflammatory disease characterized by the destruction of tooth-supporting tissues, often caused by specific microorganisms. In addition to clinical evaluation, radiographic assessment of alveolar bone loss is essential for the diagnosis, treatment planning, and prognosis of periodontal diseases. Panoramic radiography is widely used in oral and maxillofacial imaging and can provide valuable information about cortical and trabecular bone structures through quantitative methods.
Fractal analysis is a mathematical approach that measures the complexity and trabecular patterns of bone. It has been shown to be independent of projection geometry and is commonly applied in digital radiographs. The fractal dimension (FD) reflects the degree of trabecular complexity and can serve as a numerical indicator of bone microarchitecture. The box-counting method, as described by White and Rudolph, will be employed in this study using ImageJ software. In addition to fractal analysis, morphometric indices such as the mental index (MI) and panoramic mandibular index (PMI) will be calculated to assess mandibular cortical thickness and morphology.
This retrospective observational study will include 120 panoramic radiographs obtained from the archives of the Department of Oral and Maxillofacial Radiology, Istanbul University Faculty of Dentistry. The study group will consist of patients with a confirmed diagnosis of periodontitis according to the 2017 classification by the European Federation of Periodontology and the American Academy of Periodontology, while the control group will include systemically healthy individuals with no periodontal disease. Exclusion criteria include individuals under 18 years of age, those with systemic or syndromic conditions, and radiographs with diagnostic errors.
Radiographic measurements will be performed independently by two oral and maxillofacial radiologists, and intra- and inter-observer agreement will be tested through repeated evaluations. Statistical analyses will be conducted using NCSS 2007 software, applying descriptive statistics, Shapiro-Wilk test for normality, independent t-test or Mann-Whitney U test for group comparisons, and chi-square tests for categorical data, with a significance level of p<0.05.
The study is expected to reveal quantitative differences in mandibular bone structure between individuals with periodontitis and healthy controls. The results may contribute to improved diagnostic accuracy of panoramic radiographs in periodontal disease and provide additional tools for early detection and risk assessment in clinical practice.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis Group | – | –Individuals diagnosed with periodontitis based on 2017 EFP/AAP classification |
| Healthy Control Group | – | –Systemically and periodontally healthy individuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adults aged 18 years and older who underwent panoramic radiographic examinations at the Department of Oral and Maxillofacial Radiology, Istanbul University. The case group included patients diagnosed with periodontitis based on clinical and radiographic criteria, while the control group included periodontally and systemically healthy individuals.
Key inclusion criteria (3 listed)
- Individuals aged 18 or older
- Patients with clinically and radiographically diagnosed periodontitis (case group)
- Periodontally and systemically healthy individuals (control group)
Key exclusion criteria (3 listed)
- Individuals younger than 18
- Patients with systemic or syndromic conditions affecting bone structure
- Panoramic radiographs with artifacts or diagnostic errors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in fractal dimension values between periodontitis and healthy groups
Time frame: At baseline
Fractal dimension (FD) values of mandibular bone will be measured from panoramic radiographs using ImageJ software and compared between periodontitis patients and healthy controls.
1 secondary outcome
Differences in morphometric indices between groups
Time frame: At baseline
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 7 Oct 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Periodontitis and Panoramic Radiography, run by Istanbul University 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 3 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 7 Oct 2025. 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?
Difference in fractal dimension values between periodontitis and healthy groups (time frame: At baseline). 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 7 Oct 2025.