Clinical trial NCT06374329: Effect of Interceptive Strategies on the Clinical Outcome of Impacted Maxillary Permanent Canines
Official title: Effect of Interceptive Strategies on the Clinical Outcome of Impacted Maxillary Permanent Canines - RCT Phase 2
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tooth Impaction
Canine Teeth
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: University of Copenhagen
name: Palacky University
name: The University of Hong Kong
First posted: 2024-04-18
Enrollment: 75
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Position of the impacted maxillary canine towards the dental midline (3^ML).
timeFrame: 18 months
Secondary outcomes:
measure: Need for subsequent interventions (extraction of deciduous or permanent teeth, other orthodontic interventions, surgical exposure)
timeFrame: 18 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven - Service of Dentistry, Unit of Orthodontics
city: Olomouc
country: Czech Republic
facility: Institute of Dentistry and Oral Sciences, Faculty of Medicine and Dentistry, Palacký University
city: Hong Kong
country: Hong Kong
facility: Faculty of Dentistry
Study officials:
References:
citation: 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.