Evaluation of Mandibular Bone Microstructure Changes After Periodontal Treatment (M-BONE Study)

March 24, 2026 updated by: Nezahat Arzu Kayar, Akdeniz University

Evaluation of Mandibular Bone Microstructure Changes After Non-Surgical Periodontal Therapy Using Fractal Analysis

This retrospective 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.

Previously collected 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 retrospective observational study was conducted using previously collected 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • KONYAALTI
      • Antalya, KONYAALTI, Turkey (Türkiye), 07700
        • Akdeniz University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TBAEK-283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy and confidentiality considerations related to retrospective clinical data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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