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Completed

NCT Number: NCT05629312

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

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).

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Key information

Conditions

Tooth, Impacted Stomatognathic Diseases Tooth Diseases

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

About this study

The detailed information regarding methodology has been entered in following sections

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maxillary expansion

Procedure

The upper jaw is expanded with a removable expansion plate

Extraction of deciduous upper canines

Procedure

Both deciduous upper canines are extracted in this group

Primary outcomes

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

    Time frame: 18 months

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

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

    Time frame: After the first 18 months of follow up

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

Secondary outcomes

  1. Sector Where the Canine is Located

    Time frame: 18 months

    The sector is the position where the canine overlaps with adjacent teeth in a panoramic radiograph. The distance between the dental midline and the premolars is divided in 5 equally large spaces (units or categories 0 to 4) defined as follows: 0 = normal position (the cusp of the definitive canine is at the primary canine), 1 = distal to the long axis of the lateral incisor, 2 = mesial to the long axis of the lateral incisor, 3 = distal to the long axis of the central incisor, or 4 = mesial to the long axis of the central incisor This outcome measurement refers to the change in the Sector category where the canine is located, measured on a panoramic RX

  2. Angulation of the Canine Towards the Dental Midline

    Time frame: 18 months

    Change in the Angulation of the canine towards the dental midline, measured on a panoramic RX

  3. Angulation of the Canine Towards the First Premolar

    Time frame: 18 months

    Change in the Angulation of the canine towards the first premolar

  4. Distance Between the Canine Cusp and the Midline

    Time frame: 18 months

    Change in the Distance between the canine cusp and the midline

  5. Distance Between the Canine Cusp and the Occlusal Plane

    Time frame: 18 months

    Chenge in the Distance between the canine cusp and the occlusal plane, measured on a

  6. Need for Further Minor and/or Major Orthodontic Intervention

    Time frame: 18 months after baseline

    Need for further minor and/or major orthodontic interventions

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Nov 29, 2022
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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