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

NCT06374329 | Active Not Recruiting DMC

• 1 other identifier: S68717
• Study Type: interventional
• Target: 75
• Locations: 3 countries
• Sites: 3

Brief Summary

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.

Conditions

Tooth Impaction; Canine Teeth

Outcome Measures

Primary Outcomes (1)

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

  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

  18 months

Secondary Outcomes (1)

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

  18 months

Study Arms (3)

Posterior crossbite and lack of space (Group A - Expansion)

EXPERIMENTAL

Patients with at least one impacted maxillary canine, uni or bilateral posterior crossbite and lack of space in the upper arch will be treated with slow maxillary expansion with removable plates (GROUP A - expansion)

Other: Interceptive Slow Maxillary Expansion with removable plates

No Posterior crossbite and lack of space (Group B - Expansion)

EXPERIMENTAL

Patients with at least one impacted maxillary canine, no uni or bilateral posterior crossbite and lack of space in the upper arch will be treated with slow maxillary expansion with removable plates (GROUP B - expansion) . Inclusion in groups B and C will be randomized

Other: Interceptive Slow Maxillary Expansion with removable plates

No Posterior crossbite and lack of space (Group C - Expansion)

NO INTERVENTION

Patients with at least one impacted maxillary canine, no uni or bilateral posterior crossbite and lack of space in the upper arch will receive no treatment and will be simply followed up (GROUP C - No intervention) Inclusion in groups B and C will be randomized

Interventions

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

No Posterior crossbite and lack of space (Group B - Expansion); Posterior crossbite and lack of space (Group A - Expansion)

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Karolinska Institutet: collaborator
• University of Copenhagen: collaborator
• Palacky University: collaborator
• The University of Hong Kong: collaborator

Study Sites (3)

University Hospitals Leuven - Service of Dentistry, Unit of Orthodontics

Leuven, 3000, Belgium

Location

Institute of Dentistry and Oral Sciences, Faculty of Medicine and Dentistry, Palacký University

Olomouc, Czechia

Location

Faculty of Dentistry

Hong Kong, Hong Kong

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 BACKGROUND

Related Links

• Department of Oral Healths Sciences - Orthodontics University KU Leuven, Belgium

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

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

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 12, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); CZ (1); HK (1)