TOMOSTEOp: Diagnostic Performances of Mandibular CBCT in Osteoporosis

Sponsor

Nantes University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05721118

Collaborator

(none)

Enrollment

Anticipated Duration (Days)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Diagnostic Test: CBCT and DXA exams performed in current practice in Nantes University Hospital

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Feb 10, 2023

Anticipated Primary Completion Date :

Feb 25, 2023

Anticipated Study Completion Date :

Feb 26, 2023

Outcome Measures

Primary Outcome Measures

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 analysis]
Sensitivity (Se), Specificity (Sp), Negative Predictive Value (NPV), Positive Predictive Value (PPV), AUC.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT05721118

Other Study ID Numbers:

TOMOSTEOp_AL_190123

First Posted:

Feb 9, 2023

Last Update Posted:

Feb 13, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoporosis

Study Results

No Results Posted as of Feb 13, 2023