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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05629312
Other study ID # S59030
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 12, 2016
Est. completion date August 30, 2025

Study information

Verified date November 2022
Source Universitaire Ziekenhuizen KU Leuven
Contact Guy Willems
Phone +32 016 3332747
Email guy.willems@uzleuven.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to investigate the effect of 3 randomly applied interceptive measures (slow maxillary expansion, extraction of deciduous canines and no intervention) on maxillary canine impaction in patients with early mixed dentition and lack of space in the dental arch. Additionally, these groups are compared with a control group with adequate space. Patients with at least one impacted maxillary canine, presence of deciduous canines and absence of crossbite were included. The canine position is assessed by measuring five variables (sector of the canine cusp, canine to midline angle, canine to first premolar angle, canine cusp to midline distance, and canine cusp to maxillary plane distance) on 2 panoramic radiographs at 0 (T1) and 18 months (T2).


Description:

The detailed information regarding methodology has been entered in following sections


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 30, 2025
Est. primary completion date August 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 11 Years
Eligibility Inclusion Criteria: - All patients presenting at the intake consultation of the Department of Orthodontics of University Hospitals Leuven, Belgium from September 2016, with at least one maxillary permanent canine impaction are invited to participate. Canine impaction is diagnosed based on a panoramic radiograph, taken for standard evaluation of dental development and associated pathology. A maxillary canine is considered to be impacted when the canine to midline angle was =15° (Alqerban et al. 2014; Warford et al. 2003). Only impacted maxillary canines with incomplete root formation and with persisting deciduous canines are included. Exclusion Criteria: - presence of uni- or bilateral posterior dental crossbite, - upper permanent canines showing root malformation, ankylosis or fully erupted, - evidence of root resorption of adjacent teeth, previous orthodontic treatment, - craniofacial syndromes, - systemic disease that would impede orthodontic treatment/surgery and recent exposure to radiotherapy. - large eruption follicles seen on the permanent canines

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Maxillary expansion
The upper jaw is expanded with a removable expansion plate
Extraction of deciduous upper canines
Both deciduous upper canines are extracted in this group

Locations

Country Name City State
Belgium UZ Leuven Leuven Vlaams Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of definitive upper canines that erupt spontaneously up to 18 months of follow up Spontaneous eruption of definitive upper canines 18 months
Primary Number of definitive upper canines that erupt spontaneously after 18 months of follow up Spontaneous eruption of definitive upper canines After the first 18 months of follow up
Secondary Sector where the canine is located Improvement of the Sector where the canine is located, measured on a panoramic RX 18 months
Secondary Angulation of the canine towards the dental midline Improvement of the Angulation of the canine towards the dental midline, measured on a panoramic RX 18 months
Secondary Angulation of the canine towards the first premolar Improvement of the Angulation of the canine towards the first premolar, measured on a 18 months
Secondary Distance between the canine cusp and the midline Improvement of the Distance between the canine cusp and the midline, measured on a 18 months
Secondary Distance between the canine cusp and the occlusal plane Improvement of the Distance between the canine cusp and the occlusal plane, measured on a 18 months
Secondary Need for further minor and/or major orthodontic intervention Need for further minor and/or major orthodontic intervention After 18 months of Follow up
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