Diagnostic Performances of Mandibular CBCT in Osteoporosis

Osteoporosis Clinical Trial

— TOMOSTEOp  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05721118
• Other study ID #: TOMOSTEOp_AL_190123
• Status: Not yet recruiting
• Start date: March 8, 2023
• Est. completion date: March 10, 2023

Study information

• Verified date: February 2023
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 10, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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%)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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