Clinical trial NCT05721118: Diagnostic Performances of Mandibular CBCT in Osteoporosis
Official title: Diagnostic Performances of Mandibular CBCT Versus DXA Gold-Standard in Bone Mineral Density Assessment and Osteoporosis Diagnosis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: \>65 years old post-menopausal women who performed contemporaneously (ie. maximum 3months delay)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of diagnostic performances of CBCT multivariate explicative model of osteoporosis regarding DXA T-Score Gold-Standard (-2,5DS).
timeFrame: Day1 of retrospective CBCT/DXA acquisition analysis
Secondary outcomes:
Other outcomes:
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