Trials / Unknown
UnknownNCT05721118
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (estimated)
- Sponsor
- Nantes University Hospital · Academic / Other
- Sex
- Female
- Age
- 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | CBCT 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%) |
Timeline
- Start date
- 2023-03-08
- Primary completion
- 2023-03-10
- Completion
- 2023-03-10
- First posted
- 2023-02-09
- Last updated
- 2023-02-28
Source: ClinicalTrials.gov record NCT05721118. Inclusion in this directory is not an endorsement.