NCT06395077

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2022

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

April 29, 2024

Last Update Submit

April 29, 2024

Conditions

Alveolar Cleft

Keywords

CBCTLow-doseAlveolar cleft

Outcome Measures

Primary Outcomes (1)

  • Evaluation of post grafting in patients with clefts.

    CBCT investigation after surgery of patients with alveolar clefts.

    2 years

Interventions

CBCT low-dose protocolDIAGNOSTIC_TEST

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).

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kristina Hellen-Halme

Malmo, 20250, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 39497332DERIVED

Study Officials

  • Kristina Hellén-Halme

    Malmo university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 1, 2024

Study Start

May 26, 2021

Primary Completion

June 17, 2022

Study Completion

February 25, 2024

Last Updated

May 1, 2024

Record last verified: 2024-04

Locations

SE(1)