Clinical trial NCT04608708: 3D Analysis of Cemento-Osseous Lesions
Official title: A Retrospective Radiological Analysis of Cemento-Osseous Dysplasia Using 3D Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Diseases
Cone-beam Computed Tomography
Florid Cemento-osseous Dysplasia
Keywords: Bone Diseases
Cone-beam computed tomography
Florid cemento-osseous dysplasia
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 46
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
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

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

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.

Eligibility 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.

Primary outcomes:
measure: the correlation between presence of cemento osseous dysplasia and gender/ age
timeFrame: for three months from the beginning of the study
measure: cemento osseous dysplasia lesion's location and relationship with the anatomical structures
timeFrame: for three months from the beginning of the study
measure: cemento osseous dysplasia lesions dimensional measurement of the lesions
timeFrame: for three months from the beginning of the study
measure: cemento osseous dysplasia lesions volume of the lesions
timeFrame: for three months from the beginning of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University Training and Research Hospital
Study officials:
affiliation: Recep Tayyip Erdogan University Training and Research Hospital
name: Dilara Nil Günaçar
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.