3D Analysis of Cemento-Osseous Lesions

Bone Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04608708
• Other study ID #: 2020/189
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Bone Diseases
• Cone-beam Computed Tomography
• Florid Cemento-osseous Dysplasia

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