NCT04608708

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

5 months

First QC Date

October 21, 2020

Last Update Submit

October 28, 2020

Conditions

Keywords

Bone DiseasesCone-beam computed tomographyFlorid cemento-osseous dysplasia

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (3)

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

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

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

Interventions

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 1. Periapical Cemento-Osseous DysplasiaGroup 2. Focal Cemento-Osseous DysplasiaGrup 3. Florid Cemento-Osseous Dysplasia

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • Radiographs with insufficient diagnostic images were not included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University Training and Research Hospital

Rize, 53100, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 32076867BACKGROUND
  • 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.

    PMID: 31846355BACKGROUND

MeSH Terms

Conditions

Bone DiseasesFlorid cemento-osseous dysplasia

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

  • Dilara Nil Günaçar

    Recep Tayyip Erdogan University Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 21, 2020

First Posted

October 29, 2020

Study Start

October 22, 2019

Primary Completion

March 10, 2020

Study Completion

October 21, 2020

Last Updated

October 29, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

e-identified individual participant data for all measures will be made available

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available 5 years after publication
Access Criteria
Data access requests will be reviewed by authors.

Locations