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

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

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

Study Overview

• Status: Completed
• Conditions: Alveolar Cleft
• Intervention / Treatment: Diagnostic test: CBCT low-dose protocol

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• Sweden
  • Malmo, Sweden, 20250
    • Kristina Hellen-Halme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

patients with oral facial clefts who had undergone alveoalar bone grafting. Healing control after 6 months.

Description

Inclusion Criteria:

• patients with oral facial clefts who had undergone alveoalar bone grafting. Healing control after 6 months.

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of post grafting in patients with clefts.	CBCT investigation after surgery of patients with alveolar clefts.	2 years

Collaborators and Investigators

• Sponsor: Malmö University
• Collaborators: Region Skane
• Investigators: Principal Investigator: Kristina Hellén-Halme, Malmö University

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Actual): June 17, 2022
• Study Completion (Actual): February 25, 2024

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: CBCT; Low-dose; Alveolar cleft
• Other Study ID Numbers: FO 2020/401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No