Diagnostic Performances of Mandibular CBCT in Osteoporosis
TOMOSTEOp
1 other identifier
observational
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2023
CompletedFirst Posted
Study publicly available on registry
February 9, 2023
CompletedStudy Start
First participant enrolled
March 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2023
CompletedFebruary 28, 2023
February 1, 2023
2 days
January 31, 2023
February 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of diagnostic performances of CBCT multivariate explicative model of osteoporosis regarding DXA T-Score Gold-Standard (-2,5DS).
Sensitivity (Se), Specificity (Sp), Negative Predictive Value (NPV), Positive Predictive Value (PPV), AUC.
Day1 of retrospective CBCT/DXA acquisition analysis
Interventions
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%)
Eligibility Criteria
\>65 years old post-menopausal women who performed contemporaneously (ie. maximum 3months delay)
You may qualify if:
- \> 65 years old post-menauposal women
- Contemporanean (ie. 3months) CBCT and DXA exams performed in Nantes University Hospital.
You may not qualify if:
- \< 65 years old post-menauposal women
- CBCT and DXA exams interval superior to 3months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Legrand A, Autrusseau F, Bandiaky ON, Idiri K, Le Goff B, Amador G, Volteau C, Maugars Y, Soueidan A. Promising diagnostic performance of CBCT-based TOMOSTEOp algorithm in osteoporosis: toward a complementary populational screening tool managed by dentists? Osteoporos Int. 2023 Jun;34(6):1137-1138. doi: 10.1007/s00198-023-06724-8. Epub 2023 Mar 31. No abstract available.
PMID: 37000207DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2023
First Posted
February 9, 2023
Study Start
March 8, 2023
Primary Completion
March 10, 2023
Study Completion
March 10, 2023
Last Updated
February 28, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share
Anonymized data. No sharing.