Diagnostic Performances of Mandibular CBCT in Osteoporosis

NCT ID: NCT05721118

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-08

Study Completion Date

2023-03-10

Brief Summary

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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

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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

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Osteoporosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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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%)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 37000207 (View on PubMed)

Other Identifiers

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TOMOSTEOp_AL_190123

Identifier Type: -

Identifier Source: org_study_id

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