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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04608708
Other study ID # 2020/189
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 22, 2019
Est. completion date October 21, 2020

Study information

Verified date October 2020
Source Recep Tayyip Erdogan University Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date October 21, 2020
Est. primary completion date March 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Turkey Recep Tayyip Erdogan University Training and Research Hospital Rize

Sponsors (1)

Lead Sponsor Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Kato CN, Barra SG, Pereira MJ, Gomes LT, Amaral TM, Abreu LG, Brasileiro CB, Mesquita RA. Mandibular radiomorphometric parameters of women with cemento-osseous dysplasia. Dentomaxillofac Radiol. 2020 May 1;49(4):20190359. doi: 10.1259/dmfr.20190359. Epub 2019 Dec 20. — View Citation

Kato CNAO, Barra SG, Amaral TMP, Silva TA, Abreu LG, Brasileiro CB, Mesquita RA. Cone-beam computed tomography analysis of cemento-osseous dysplasia-induced changes in adjacent structures in a Brazilian population. Clin Oral Investig. 2020 Aug;24(8):2899-2908. doi: 10.1007/s00784-019-03154-x. Epub 2020 Feb 19. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary the correlation between presence of cemento osseous dysplasia and gender/ age 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
Primary cemento osseous dysplasia lesion's location and relationship with the anatomical structures 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
Primary cemento osseous dysplasia lesions dimensional measurement of the lesions 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
Primary cemento osseous dysplasia lesions volume of the lesions 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
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