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

NCT ID: NCT05629312

Last Updated: 2025-03-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-12

Study Completion Date

2023-10-30

Brief Summary

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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).

Detailed Description

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The detailed information regarding methodology has been entered in following sections

Conditions

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Tooth, Impacted

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Maxillary expansion

All included patients (in all arms) present (at least one) maxillary canine impaction.

Patients in this arm present also lack of space in the upper jaw and are treated with maxillary expansion

Group Type EXPERIMENTAL

Maxillary expansion

Intervention Type PROCEDURE

The upper jaw is expanded with a removable expansion plate

Extraction of deciduous canines

All included patients (in all arms) present (at least one) maxillary canine impaction.

Patients in this arm present also lack of space in the upper jaw and are treated with extraction of deciduous canines

Group Type EXPERIMENTAL

Extraction of deciduous upper canines

Intervention Type PROCEDURE

Both deciduous upper canines are extracted in this group

No intervention

All included patients (in all arms) present (at least one) maxillary canine impaction.

Patients in this arm present also lack of space in the upper jaw and no intervention is performed

Group Type NO_INTERVENTION

No interventions assigned to this group

Control

All included patients (in all arms) present (at least one) maxillary canine impaction.

Patients in this arm do not present lack of space in the upper jaw and no intervention is performed

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Maxillary expansion

The upper jaw is expanded with a removable expansion plate

Intervention Type PROCEDURE

Extraction of deciduous upper canines

Both deciduous upper canines are extracted in this group

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Cadenas

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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UZ Leuven

Leuven, Vlaams Brabant, Belgium

Site Status

Countries

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Belgium

References

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Willems G, Butaye C, Raes M, Zong C, Begnoni G, Cadenas de Llano-Perula M. Early prevention of maxillary canine impaction: a randomized clinical trial. Eur J Orthod. 2023 Jul 31;45(4):359-369. doi: 10.1093/ejo/cjad014.

Reference Type DERIVED
PMID: 37266982 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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S59030

Identifier Type: -

Identifier Source: org_study_id

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