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NCT Number: NCT06374329

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

Canine impaction is a sign of abnormal dental development with potentially far-reaching consequences (such as significant root resorption and loss of lateral incisors. This compromises both aesthetics and function of the teeth, making the prediction of canine tooth impaction increasingly important. Interceptive orthodontic measures, such as extraction of deciduous canines or molars or maxillary expansion aim to create extra space in the dental arch, allowing the canines to position themselves better and normalizing their eruption pattern.

This study corresponds to the second phase of an RCT, based on the results of the first phase, published in July 2023 (S59030) (Willems G, Butaye C, Raes M, Zong C, Begnoni G, Cadenas de Llano-Pérula M. Early prevention of maxillary canine impaction: a randomized clinical trial. Eur J Orthod. 31;45(4):359-369). The first phase compared the effect of 3 interceptive strategies (expansion, extraction and no intervention) on the position of impacted maxillary canines, finding that maxillary expansion provides the most improvement on impacted canine position. In second phase, 8-year-old patients without posterior crossbite and lack of space in the dental arch are randomized to treatment with 'slow maxillary expansion with removable plates' or 'no treatment'. These groups are additionally compared with patients with a crossbite and lack of space, which always receive expansion treatment. All selected patients will be followed up for at least 18 months. The primary endpoint is to investigate the effect of maxillary expansion with removable plates on the position of maxillary canines prone to impaction during early mixed dentition, assessed on panoramic X-rays. The secondary endpoint is the assessment of the need for additional orthodontic treatment.

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Key information

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven - Service of Dentistry, Unit of Orthodontics, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

General inclusion criteria:

  • Female or male patients between 7.5 and 9.5 years-old coming to the department of Orthodontics of UZ Leuven (or one of the participating centres) seeking for orthodontic advice.
  • Presenting with one or two impacted maxillary permanent canines, defined by 3¨ML between 15 and 45 degrees (If bilateral impaction occurs, categorization into the different protocol groups will be based on the canine showing the worst position).
  • Presenting with one or two maxillary permanent canines showing no more than ¾ root formation, persisting deciduous canines and molars and lack of space in the maxillary arch, defined by ALD>0 mm
  • Any race Inclusion criteria Group A: posterior crossbite Inclusion criteria Groups B and C: no posterior crossbite

Exclusion criteria

  • Fully erupted permanent canines
  • Previous orthodontic treatment.
  • Canines with completed root formation
  • Evidence of root resorption of adjacent teeth or root malformation of the canines that would obligate to extract any adjacent teeth or the canine(s).
  • Craniofacial syndromes
  • Systemic disease that would impede orthodontic treatment/surgery
  • Recent exposure to radiotherapy.

Treatment and study plan

Interceptive Slow Maxillary Expansion with removable plates

Other

Interceptive Slow Maxillary Expansion with removable plates (see Willems et al 2023) https://doi.org/10.1093/ejo/cjad014

Primary outcomes

  1. Position of the impacted maxillary canine towards the dental midline (3^ML).

    Time frame: 18 months

    Longitudinal difference in the position of the impacted maxillary canine towards the dental midline (3^ML), measured radiologically on panoramic radiographs before the study and at 18 months follow up

Secondary outcomes

  1. Need for subsequent interventions (extraction of deciduous or permanent teeth, other orthodontic interventions, surgical exposure)

    Time frame: 18 months

    Need for subsequent interventions (extraction of deciduous or permanent teeth, other orthodontic interventions, surgical exposure)

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Karolinska Institutet
  • Palacky University
  • The University of Hong Kong
  • University of Copenhagen

Registry information

Official study title

Effect of Interceptive Strategies on the Clinical Outcome of Impacted Maxillary Permanent Canines - RCT Phase 2

Acronym: RCTcanines2

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 18, 2024
Registry last updated
Mar 12, 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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