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
• Status: Completed
• 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
• 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
• 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: -

Related Conditions & MeSH terms

• Alveolar Cleft

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