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Diagnostic Performances of Mandibular CBCT in Osteoporosis

Diagnostic Performances of Mandibular CBCT Versus DXA Gold-Standard in Bone Mineral Density Assessment and Osteoporosis Diagnosis.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05721118
Acronym
TOMOSTEOp
Enrollment
40
Registered
2023-02-09
Start date
2023-03-08
Completion date
2023-03-10
Last updated
2023-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Brief summary

In the last decade, there has been a shift towards Cone-Beam Computed Tomography (CBCT - regarding its low-dose radiation profile) in Dentistry/Implantology fields because it presents a more conclusive insight in the bone micro-architecture and cortical/trabecular bone structures assessment due to 3D acquisition higher resolution. Despite convergent and interesting preliminary results, most CBCT studies failed in highlighting a potential new osteoporosis diagnostic tool. TOMOSTEOp study aims to explore inter-relation between CBCT parameters and DXA Gold-Standard parameters in order to build resolutive explicative model of bone mineral density and test CBCT diagnostic performances.

Detailed description

In the last decade, there has been a shift towards Cone-Beam Computed Tomography (CBCT - regarding its low-dose radiation profile) in Dentistry/Implantology fields because it presents a more conclusive insight in the bone micro-architecture and cortical/trabecular bone structures assessment due to 3D acquisition higher resolution. Despite convergent and interesting preliminary results, most CBCT studies failed in highlighting a potential new osteoporosis diagnostic tool. TOMOSTEO aims to explore inter-relation between CBCT parameters and DXA Gold-Standard parameters in order to build resolutive explicative model of bone mineral density and test CBCT diagnostic performances. TOMOSTEOp study will analyze CBCT and DXA acquisitions of \>65 years old post-menopausal women who performed contemporaneously (ie. maximum 3months delay) these 2 exams. Radiomorphometric (I/S/CTMI/CTI(S)/CTI(I)), Gray Values (cortical and trabecular) and Fractal Dimension Indexes will be measured on the whole mandibular arch, as well as cortical/trabecular thicknesses. Correlations and odds-ratio will be calculated regarding DXA parameters and T-scores (-2,5DS). Differences between osteopenic, osteoporotic and healthy women will be explored.

Interventions

DIAGNOSTIC_TESTCBCT and DXA exams performed in current practice in Nantes University Hospital

40 patients will be enrolled in order to study DXA/CBCT acquisitions of 16 osteoporotic women vs 34 osteopenic/healthy women (Estimated osteoporotic rate = 20%)

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* \> 65 years old post-menauposal women * Contemporanean (ie. 3months) CBCT and DXA exams performed in Nantes University Hospital.

Exclusion criteria

* \< 65 years old post-menauposal women * CBCT and DXA exams interval superior to 3months.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of diagnostic performances of CBCT multivariate explicative model of osteoporosis regarding DXA T-Score Gold-Standard (-2,5DS).Day1 of retrospective CBCT/DXA acquisition analysisSensitivity (Se), Specificity (Sp), Negative Predictive Value (NPV), Positive Predictive Value (PPV), AUC.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026