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Validation of X-ray Protocols in Cleft Children

NCT05351372 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-05-04

No results posted yet for this study

Summary

Children born with an alveolar cleft receive bone grafts for improved function and aesthetics. The cleft area is radiologically examined before and post bone graft. Optimizing x-ray examination protocols is essential to protect these patients from possible delayed radiation injury later in life. This study investigates whether image quality of cone-beam computed tomography (CBCT) exposed with an ultra-low dose (ULD) protocol is comparable to the clinical default protocol, the standard dose (SD) protocol, in visualizing details of importance in bone grafting of alveolar clefts.

Methods In this randomized controlled study, 72 patients with uni- or bilateral alveolar clefts between 9-19 years (mean age 9.5) were randomized 1:1 with either a ULD or an SD CBCT examination protocol. The CBCT scans were conducted with Planmeca ProMax Mid with an 8x5cm field of view. Two experienced radiologists blindly evaluated the images and visibility of cortical bone border, trabecular bone, tooth anatomy, root development, periodontal space, and cleft width. The visibility was categorized as unacceptable, acceptable, or excellent.

Conditions

  • Evaluate CBCT Protocols in Subjective Image Quality

Interventions

RADIATION

Ultra-low dose protocol

RADIATION

Standard dose protocol

Sponsors & Collaborators

Principal Investigators

  • Xie-qi Shi, PhD · University of Bergen

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-05-18
Completion
2017-05-18

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05351372 on ClinicalTrials.gov