3D Analysis of Cemento-Osseous Lesions

October 28, 2020 updated by: DİLARA NİL GÜNAÇAR, Recep Tayyip Erdogan University Training and Research Hospital

A Retrospective Radiological Analysis of Cemento-Osseous Dysplasia Using 3D Imaging

COD lesions effect a wide range of different anatomical areas, show different volume and morphometric characteristics.

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Fibro-osseous lesions of the jaws are one of the important lesion groups for which identification and diagnosis create clinical difficulties. In previous studies, the features of the lesions and the effects of COD on anatomical structures were analysed via CBCT images by measuring the lesion's dimensions linearly for the first time in the Brazilian population. However, 3D measurements of the volume need to be taken to assess the actual spread over adjacent anatomical structures. The purpose of this retrospective study is to measure the volume of the lesions that have been diagnosed as COD in the Turkish population by using 3D images. This will contribute to an advanced study conducted on the global population to observe a change in these morphologies with respect to different geographical and ethnic origins.

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.
46

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
      • Rize, Turkey, 53100
        • Recep Tayyip Erdogan University Training and Research Hospital

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
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

diagnosed with fibro-osseous lesions with the help of cone beam computed tomography between 2017 and 2020 were included in the study

Description

Inclusion Criteria:

  • They were diagnosed with fibro-osseous lesions with the help of cone beam computed tomography between 2017 and 2020 were included in the study.
  • The lesions diagnosed radiologically and followed up for at least one year were included in this study.

Exclusion Criteria:

-Radiographs with insufficient diagnostic images were not included.

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

  • Observational Models: Case-Crossover
  • Time Perspectives: Cross-Sectional

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.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1. Periapical Cemento-Osseous Dysplasia
In Periapical Cemento-Osseous Dysplasia , the lower anterior teeth are usually affected. In these lesions, normal bone is replaced by fibrous tissue that contains amorphous vascularised calcifications. In the early stage, it can mimic a periapical lesion, but it is usually associated with vital teeth, without any clinical complaint, and it requires no intervention. Histopathologically, the lesion is similar to fibrous dysplasia and ossifying fibroma.
Other: The data of patients who had applied to the clinic for various reasons and were diagnosed with fibro-osseous lesions
lesions diagnosed radiologically and followed up for at least one year were included in this study with the help of cone beam computed tomography.
Group 2. Focal Cemento-Osseous Dysplasia
It occurs in a single area of the posterior teeth. Its radiographic and histolopathological features are similar to Periapical Cemento-Osseous Dysplasia
Other: The data of patients who had applied to the clinic for various reasons and were diagnosed with fibro-osseous lesions
lesions diagnosed radiologically and followed up for at least one year were included in this study with the help of cone beam computed tomography.
Grup 3. Florid Cemento-Osseous Dysplasia
When the lesions involve two or more quadrants of the jaw, it is defined as Florid Cemento-Osseous Dysplasia. Its radiographic and histolopathological features are similar to Periapical Cemento-Osseous Dysplasia
Other: The data of patients who had applied to the clinic for various reasons and were diagnosed with fibro-osseous lesions
lesions diagnosed radiologically and followed up for at least one year were included in this study with the help of cone beam computed tomography.

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
the correlation between presence of cemento osseous dysplasia and gender/ age
Time Frame: for three months from the beginning of the study
It usually affects female and black patients. Most of the patients are initially diagnosed between the ages of 30 and 50, and the diagnosis is almost never made in individuals younger than 20
for three months from the beginning of the study
cemento osseous dysplasia lesion's location and relationship with the anatomical structures
Time Frame: for three months from the beginning of the study
If the lesions were in association with the teeth, the teeth numbers were recorded. The periphery of the lesions was divided into two sections: well-defined (corticated, sclerotic, non-corticated and partially corticated) and ill-defined (perforating, diffuse and invasive). The shape of the lesion was classified as circular, oval or irregular. The presence of a hypodense capsule was assessed as present, absent or partially present. The involvement with the adjacent structures - cortical bone (lingual and buccal), mandibular canal, mental foramen, nasopalatinal canal, incisive foramen, maxillary sinus, nasal fossa and anterior mandibular canal - was assessed and recorded. The effects on the cortical bone were assessed as intact, thinning, expansion and thinning, thinning and perforation, expansion, thinning and perforation or perforation. The internal calcified parts of the lesions.
for three months from the beginning of the study
cemento osseous dysplasia lesions dimensional measurement of the lesions
Time Frame: for three months from the beginning of the study

The internal calcified parts of the lesions and the total volume of the lesions were also assessed.

The greatest linear dimension of the buccolingual, buccopalatinal and mesiodistal positions was measured on the axial plane, while the supero-inferior dimension was measured on sagittal or cross-sectional images.
for three months from the beginning of the study
cemento osseous dysplasia lesions volume of the lesions
Time Frame: for three months from the beginning of the study
The internal calcified parts of the lesions and the total volume of the lesions were also assessed.
for three months from the beginning of the study

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.
Recep Tayyip Erdogan University Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dilara Nil Günaçar, Recep Tayyip Erdogan University Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
October 22, 2019

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.
March 10, 2020

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.
October 21, 2020

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).
October 21, 2020

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.
October 28, 2020

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.
October 29, 2020

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.
October 29, 2020

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.
October 28, 2020

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.
October 1, 2020

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.
  • 2020/189

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

e-identified individual participant data for all measures will be made available

IPD Sharing Time Frame

Data will be available 5 years after publication

IPD Sharing Access Criteria

Data access requests will be reviewed by authors.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

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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