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

NCT ID: NCT06395077

Last Updated: 2024-05-01

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-26

Study Completion Date

2024-02-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alveolar Cleft

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Region Skane

OTHER

Sponsor Role collaborator

Malmö University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kristina Hellén-Halme

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kristina Hellén-Halme

Role: PRINCIPAL_INVESTIGATOR

Malmo university

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kristina Hellen-Halme

Malmo, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Vicente A, Cederhag J, Rashidi N, Wiedel AP, Becker M, Brogardh-Roth S, Shi XQ, Hellen-Halme K. Low-Dose Cone-Beam Computed Tomography in Swedish Pediatric Patients With Alveolar Clefts Following Alveolar Bone Grafting-A Clinical Study. Clin Exp Dent Res. 2024 Dec;10(6):e70021. doi: 10.1002/cre2.70021.

Reference Type DERIVED
PMID: 39497332 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FO 2020/401

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Knee Injury Decision
NCT02856945 UNKNOWN
Role of CT in Tetralogy of Fallot Diagnosis
NCT07247435 NOT_YET_RECRUITING