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3D Analysis of Cemento-Osseous Lesions

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ClinicalTrials.gov Identifier: NCT04608708
Recruitment Status : Completed
First Posted : October 29, 2020
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
DİLARA NİL GÜNAÇAR, Recep Tayyip Erdogan University Training and Research Hospital

Study Description
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Brief Summary:
COD lesions effect a wide range of different anatomical areas, show different volume and morphometric characteristics.

Condition or disease Intervention/treatment
Bone Diseases Cone-beam Computed Tomography Florid Cemento-osseous Dysplasia Other: The data of patients who had applied to the clinic for various reasons and were diagnosed with fibro-osseous lesions

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 Design
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Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: A Retrospective Radiological Analysis of Cemento-Osseous Dysplasia Using 3D Imaging
Actual Study Start Date : October 22, 2019
Actual Primary Completion Date : March 10, 2020
Actual Study Completion Date : October 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Diseases

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   Yes
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
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04608708


Locations
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Turkey
Recep Tayyip Erdogan University Training and Research Hospital
Rize, Turkey, 53100
Sponsors and Collaborators
Recep Tayyip Erdogan University Training and Research Hospital
Investigators
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Principal Investigator: Dilara Nil Günaçar Recep Tayyip Erdogan University Training and Research Hospital
More Information
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Publications:

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Responsible Party: DİLARA NİL GÜNAÇAR, assistant professor, Recep Tayyip Erdogan University Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04608708    
Other Study ID Numbers: 2020/189
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: October 29, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: e-identified individual participant data for all measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be available 5 years after publication
Access Criteria: Data access requests will be reviewed by authors.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DİLARA NİL GÜNAÇAR, Recep Tayyip Erdogan University Training and Research Hospital:
Bone Diseases
Cone-beam computed tomography
Florid cemento-osseous dysplasia
Additional relevant MeSH terms:
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Bone Diseases
Musculoskeletal Diseases