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NCT06395077 Clinical Trial

Diagnostic Efficiency of Low-dose Cone-beam Computed Tomography in Post-graft Evaluation.

Alveolar Cleft Clinical Trial

Official title:
Diagnostic Efficiency of Low-dose Cone-beam Computed Tomography in Post-graft Evaluation of Swedish Paediatric Patients With Alveolar Clefts

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06395077
Other study ID # FO 2020/401
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 26, 2021
Est. completion date February 25, 2024

Study information
Verified date April 2024
Source Malmö University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluation of a Low-dose exposure CBCT protocol for post-graft evaluation of treatment of cleft patients

Description:

The patient underwent two CBCT examinations (Accuitomo 170; J Morita Corp., Kyoto, Japan): one examination followed the clinical standard-dose protocol (exposure settings: 90 kV, 5 mA, and 9.4 s), and one, the low-dose protocol (90 kV, 2 mA, 9.4 s). The field of view (FOV) was 6.0 cm x 6.0 cm, the rotation mode was 180 degrees, and voxel size was 0.125 mm. Volume was reconstructed in slices of 1-mm thickness and interval. The dose area products (DAP) were 423 mGy cm2 for the clinical, standard-dose protocol and 172 mGy cm2 for the low-dose protocol. The aim was to establish if a low-dose protocol could provide diagnostically acceptable image quality for assessing bone healing after alveolar bone grafting.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date February 25, 2024
Est. primary completion date June 17, 2022
Accepts healthy volunteers
Gender All
Age group 7 Years to 14 Years
Eligibility Inclusion Criteria: - patients with oral facial clefts who had undergone alveoalar bone grafting. Healing control after 6 months. Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• CBCT low-dose protocol
The patient underwent two CBCT examinations (Accuitomo 170; J Morita Corp., Kyoto, Japan): one examination followed the clinical standard-dose protocol (exposure settings: 90 kV, 5 mA, and 9.4 s), and one, the low-dose protocol (90 kV, 2 mA, 9.4 s).

Locations
Country Name City State
Sweden Kristina Hellen-Halme Malmo

Sponsors (2)
Lead Sponsor Collaborator
Malmö University Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of post grafting in patients with clefts. CBCT investigation after surgery of patients with alveolar clefts. 2 years
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