Bone DiseasesNCT04608708
3D Analysis of Cemento-Osseous Lesions
An observational study of Bone Diseases and Cone-beam Computed Tomography, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
COD lesions effect a wide range of different anatomical areas, show different volume and morphometric characteristics. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bone Diseases, Cone-beam Computed Tomography, Florid Cemento-osseous Dysplasia
- What is being tested?
- The data of patients who had applied to the clinic for various reasons and were diagnosed with fibro-osseous lesions
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2019to 21 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: diagnosed with fibro-osseous lesions with the help of cone beam computed tomography between 2017 and 2020 were included in the study
Who may be able to join
- 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.
Who cannot join
- -Radiographs with insufficient diagnostic images were not included.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University Training and Research Hospital
Rize, 53100
About this study
Official title: A Retrospective Radiological Analysis of Cemento-Osseous Dysplasia Using 3D Imaging
COD lesions effect a wide range of different anatomical areas, show different volume and morphometric characteristics.
Read the 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.
- Being tested
- The data of patients who had applied to the clinic for various reasons and were diagnosed with fibro-osseous lesions
- Keywords
- Bone Diseases, Cone-beam computed tomography, Florid cemento-osseous dysplasia
- Medical subject headings
- Bone Diseases, Florid cemento-osseous dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The data of patients who had applied to the clinic for various reasons and were diagnosed with fibro-osseous lesionsOther
lesions diagnosed radiologically and followed up for at least one year were included in this study with the help of cone beam computed tomography.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: Other: The data of patients who had applied to the clinic for various reasons and were diagnosed with fibro-osseous lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: for three months from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start22 Oct 2019
- Primary completion10 Mar 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİLARA NİL GÜNAÇAR, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Dilara Nil Günaçar, Principal investigator, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608708
- Sponsor's protocol ID
- 2020/189
- Status last verified
- Oct 2020
- First submitted
- 21 Oct 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: e-identified individual participant data for all measures will be made available
Publications
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.
PubMed 32076867Kato 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.
PubMed 31846355
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Radiological Analysis of Cemento-Osseous Dysplasia Using 3D Imaging
- ClinicalTrials.gov ID
- NCT04608708
- Acronym / sponsor ID
- 2020/189
- Keywords
- Bone Diseases, Cone-beam computed tomography, Florid cemento-osseous dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1. Periapical Cemento-Osseous Dysplasia | – | Other: The data of patients who had applied to the clinic for various reasons and were diagnosed with fibro-osseous lesionsIn 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. |
| Group 2. Focal Cemento-Osseous Dysplasia | – | Other: The data of patients who had applied to the clinic for various reasons and were diagnosed with fibro-osseous lesionsIt occurs in a single area of the posterior teeth. Its radiographic and histolopathological features are similar to Periapical Cemento-Osseous Dysplasia |
| Grup 3. Florid Cemento-Osseous Dysplasia | – | Other: The data of patients who had applied to the clinic for various reasons and were diagnosed with fibro-osseous lesionsWhen 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 |
Who may qualify
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- diagnosed with fibro-osseous lesions with the help of cone beam computed tomography between 2017 and 2020 were included in the study
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- -Radiographs with insufficient diagnostic images were not included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The data of patients who had applied to the clinic for various reasons and were diagnosed with fibro-osseous lesionslesions diagnosed radiologically and followed up for at least one year were included in this study with the help of cone beam computed tomography. | Other | Group 1. Periapical Cemento-Osseous Dysplasia, Group 2. Focal Cemento-Osseous Dysplasia, Grup 3. Florid Cemento-Osseous Dysplasia |
Primary outcome
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
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Background: PubMed 32076867Kato 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.
- Background: PubMed 31846355Kato 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.
- Individual participant dataSharing planned: Yes. e-identified individual participant data for all measures will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilara Nil Günaçar principal investigator
Recep Tayyip Erdogan University Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Diseases and Cone-beam Computed Tomography, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the correlation between presence of cemento osseous dysplasia and gender/ age (time frame: for three months from the beginning of the study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04608708, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.