Effect of Interceptive Strategies on the Clinical Outcome of Maxillary Impacted Canines

Tooth, Impacted Clinical Trial

Official title:

Effect of Interceptive Strategies on the Clinical Outcome of Maxillary Impacted Canines

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05629312
• Other study ID #: S59030
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Tooth, Impacted

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