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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

Recep Tayyip Erdogan University Training and Research Hospital

Investigators

  • 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)

October 22, 2019

Primary Completion (Actual)

March 10, 2020

Study Completion (Actual)

October 21, 2020

Study Registration Dates

First Submitted

October 21, 2020

First Submitted That Met QC Criteria

October 28, 2020

First Posted (Actual)

October 29, 2020

Study Record Updates

Last Update Posted (Actual)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 28, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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