PeriodontitisNCT07488403
Evaluation of Mandibular Bone Microstructure Changes After Periodontal Treatment (M-BONE Study)
An observational study of Periodontitis and Gingivitis, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This prospective study evaluates how non-surgical treatment for gum disease affects the bone of the mandible. Gum disease (periodontitis) can lead to changes in the bone supporting the teeth, but these changes are not always easy to detect with routine clinical examination. Read more about this study
- Who is it for?
- Ages 18 to 70 monthsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingivitis
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Jan 2024
- How long will I take part?
- 12 Months
- 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 to 70 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients treated at the Department of Periodontology, Akdeniz University Faculty of Dentistry, with available clinical and radiographic records suitable for retrospective evaluation. The study population includes individuals diagnosed with Stage II and Stage III periodontitis, as well as individuals with gingivitis.
Who may be able to join
- Individuals aged 18 years and older
- Patients diagnosed with Stage II or Stage III periodontitis, or gingivitis
- Patients who received non-surgical periodontal therapy
- Availability of complete clinical periodontal records
- Availability of periapical and panoramic radiographs at baseline and 6 m
Who cannot join
- Patients with systemic diseases affecting bone metabolism
- History of periodontal treatment within the last 6 months
- Use of medications affecting bone metabolism
- Pregnant or lactating individuals
- Poor quality or missing radiographic records
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Faculty of Dentistry
Antalya, KONYAALTI, 07700
About this study
Official title: Evaluation of Mandibular Bone Microstructure Changes After Non-Surgical Periodontal Therapy Using Fractal Analysis
This prospective study evaluates how non-surgical treatment for gum disease affects the bone of the mandible. Gum disease (periodontitis) can lead to changes in the bone supporting the teeth, but these changes are not always easy to detect with routine clinical examination.
prospectively collect clinical and radiographic data from patients with moderate and severe gum disease (Stage II and Stage III periodontitis), as well as individuals with gingivitis, were analyzed. All participants had received standard periodontal treatment as part of routine care. Radiographic images taken before treatment and 6 months after treatment were examined using fractal analysis, a method used to assess bone structure.
The results of this study may help improve understanding of how periodontal treatment influences bone structure and may support the use of radiographic analysis as a tool for monitoring treatment outcomes.
Read the detailed description
Periodontitis is a chronic inflammatory disease that leads to the destruction of the supporting structures of the teeth, including alveolar bone. Assessing changes in bone microstructure is important for understanding disease progression and treatment outcomes. Conventional clinical parameters may not fully reflect subtle alterations in trabecular bone architecture. Therefore, radiographic analysis methods, such as fractal analysis, have been proposed as objective tools to evaluate bone structure.
This prospective longitudinal study was conducted using clinical and radiographic data from patients treated at the Department of Periodontology, Akdeniz University Faculty of Dentistry. The study included patients diagnosed with Stage II and Stage III periodontitis, as well as individuals with gingivitis serving as a control group. All participants received non-surgical periodontal therapy as part of routine clinical care.
Periapical and panoramic radiographic images obtained at baseline and 6 months after treatment were analyzed. Fractal dimension analysis was performed on predefined regions of interest to assess changes in trabecular bone microstructure. In addition to radiographic evaluation, clinical periodontal parameters, including probing pocket depth, clinical attachment level, bleeding on probing, and plaque index, were recorded.
The primary objective of the study is to evaluate changes in mandibular bone microstructure following non-surgical periodontal therapy. Secondary objectives include assessing the relationship between radiographic findings and clinical periodontal parameters. The findings may contribute to a better understanding of bone response to periodontal treatment and support the use of fractal analysis as a quantitative tool in periodontal research and clinical practice.
- Conditions
- Periodontitis, Gingivitis
- Keywords
- periodontitis, Fractal analysis, Fractal dimension, Panoramic radiography, Periapical radiography, Gingivitis, Non-surgical periodontal therapy
- Medical subject headings
- Periodontitis, Gingivitis
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 |
|---|---|---|
| Stage II Periodontitis | Patients diagnosed with Stage II periodontitis who received non-surgical periodontal therapy. | |
| Stage III Periodontitis | Patients diagnosed with Stage III periodontitis who received non-surgical periodontal therapy. | |
| Gingivitis | Individuals with gingivitis who received routine periodontal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mandibular Bone Microstructure Assessed by Fractal Dimension
Fractal dimension values obtained from predefined regions of interest on periapical and panoramic radiographs to evaluate changes in mandibular trabecular bone microstructure before treatment and 6 months after non-surgical periodontal therapy.
Measured: Baseline and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
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 Akdeniz 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezahat Arzu Kayar, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488403
- Sponsor's protocol ID
- TBAEK-283
- Status last verified
- Jul 2026
- First submitted
- 18 Mar 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality considerations related to retrospective clinical data.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mandibular Bone Microstructure Changes After Non-Surgical Periodontal Therapy Using Fractal Analysis
- ClinicalTrials.gov ID
- NCT07488403
- Acronym / sponsor ID
- TBAEK-283
- Conditions
- Periodontitis, Gingivitis
- Keywords
- periodontitis, Fractal analysis, Fractal dimension, Panoramic radiography, Periapical radiography, Gingivitis, Non-surgical periodontal therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 23 Mar 2026 (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 prospective study evaluates how non-surgical treatment for gum disease affects the bone of the mandible. Gum disease (periodontitis) can lead to changes in the bone supporting the teeth, but these changes are not always easy to detect with routine clinical examination.
prospectively collect clinical and radiographic data from patients with moderate and severe gum disease (Stage II and Stage III periodontitis), as well as individuals with gingivitis, were analyzed. All participants had received standard periodontal treatment as part of routine care. Radiographic images taken before treatment and 6 months after treatment were examined using fractal analysis, a method used to assess bone structure.
The results of this study may help improve understanding of how periodontal treatment influences bone structure and may support the use of radiographic analysis as a tool for monitoring treatment outcomes.
Detailed description
Periodontitis is a chronic inflammatory disease that leads to the destruction of the supporting structures of the teeth, including alveolar bone. Assessing changes in bone microstructure is important for understanding disease progression and treatment outcomes. Conventional clinical parameters may not fully reflect subtle alterations in trabecular bone architecture. Therefore, radiographic analysis methods, such as fractal analysis, have been proposed as objective tools to evaluate bone structure.
This prospective longitudinal study was conducted using clinical and radiographic data from patients treated at the Department of Periodontology, Akdeniz University Faculty of Dentistry. The study included patients diagnosed with Stage II and Stage III periodontitis, as well as individuals with gingivitis serving as a control group. All participants received non-surgical periodontal therapy as part of routine clinical care.
Periapical and panoramic radiographic images obtained at baseline and 6 months after treatment were analyzed. Fractal dimension analysis was performed on predefined regions of interest to assess changes in trabecular bone microstructure. In addition to radiographic evaluation, clinical periodontal parameters, including probing pocket depth, clinical attachment level, bleeding on probing, and plaque index, were recorded.
The primary objective of the study is to evaluate changes in mandibular bone microstructure following non-surgical periodontal therapy. Secondary objectives include assessing the relationship between radiographic findings and clinical periodontal parameters. The findings may contribute to a better understanding of bone response to periodontal treatment and support the use of fractal analysis as a quantitative tool in periodontal research and clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stage II Periodontitis | – | –Patients diagnosed with Stage II periodontitis who received non-surgical periodontal therapy. |
| Stage III Periodontitis | – | –Patients diagnosed with Stage III periodontitis who received non-surgical periodontal therapy. |
| Gingivitis | – | –Individuals with gingivitis who received routine periodontal care |
Who may qualify
- Ages
- 18 to 70 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients treated at the Department of Periodontology, Akdeniz University Faculty of Dentistry, with available clinical and radiographic records suitable for retrospective evaluation. The study population includes individuals diagnosed with Stage II and Stage III periodontitis, as well as individuals with gingivitis.
Key inclusion criteria (5 listed)
- Individuals aged 18 years and older
- Patients diagnosed with Stage II or Stage III periodontitis, or gingivitis
- Patients who received non-surgical periodontal therapy
- Availability of complete clinical periodontal records
- Availability of periapical and panoramic radiographs at baseline and 6 m
Key exclusion criteria (5 listed)
- Patients with systemic diseases affecting bone metabolism
- History of periodontal treatment within the last 6 months
- Use of medications affecting bone metabolism
- Pregnant or lactating individuals
- Poor quality or missing radiographic records
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
Change in Mandibular Bone Microstructure Assessed by Fractal Dimension
Time frame: Baseline and 6 months after treatment
Fractal dimension values obtained from predefined regions of interest on periapical and panoramic radiographs to evaluate changes in mandibular trabecular bone microstructure before treatment and 6 months after non-surgical periodontal therapy.
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 22 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality considerations related to retrospective clinical data.
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Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not?
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RecruitingObservational study
Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis: A Pilot Prospective Longitudinal Observational Cohort Study
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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 Gingivitis, run by Akdeniz 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 5 inclusion and 5 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 22 Jul 2026. 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?
Change in Mandibular Bone Microstructure Assessed by Fractal Dimension (time frame: Baseline and 6 months after treatment). 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 22 Jul 2026.