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

NCT05629312 | Completed Results

• 1 other identifier: S59030
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Tooth, Impacted

Keywords

Interceptive orthodontics; maxillary canines; maxillary expansion; Tooth extraction; deciduous tooth

Outcome Measures

Primary Outcomes (2)

• Number of Definitive Upper Canines That Erupt Spontaneously up to 18 Months of Follow up

  Number of definitive upper canines that erupt spontaneously up to 18 months of follow up.

  18 months

• Number of Definitive Upper Canines That Erupt Spontaneously After 18 Months of Follow up

  Number of definitive upper canines that erupt spontaneously after 18 months of follow up..

  After the first 18 months of follow up

Secondary Outcomes (6)

• Sector Where the Canine is Located

  18 months

• Angulation of the Canine Towards the Dental Midline

  18 months

• Angulation of the Canine Towards the First Premolar

  18 months

• Distance Between the Canine Cusp and the Midline

  18 months

• Distance Between the Canine Cusp and the Occlusal Plane

  18 months

Study Arms (4)

Maxillary expansion

EXPERIMENTAL

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

Procedure: Maxillary expansion

Extraction of deciduous canines

EXPERIMENTAL

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

Procedure: Extraction of deciduous upper canines

No intervention

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

Control

NO INTERVENTION

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

Interventions

Maxillary expansion PROCEDURE

The upper jaw is expanded with a removable expansion plate

Maxillary expansion

Extraction of deciduous upper canines PROCEDURE

Both deciduous upper canines are extracted in this group

Extraction of deciduous canines

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 37266982 DERIVED

MeSH Terms

Conditions

Tooth, Impacted

Interventions

Palatal Expansion Technique

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontics, Corrective; Orthodontics; Dentistry

Results Point of Contact

• Title: Prof. Maria Cadenas
• Organization: UZLeuven

maria.cadenas@uzleuven.be

+3216332017

Study Officials

• Maria Cadenas

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 29, 2022
• Study Start: September 12, 2016
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)