Clinical trial NCT05629312: Effect of Interceptive Strategies on the Clinical Outcome of Maxillary Impacted Canines
Official title: Effect of Interceptive Strategies on the Clinical Outcome of Maxillary Impacted Canines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth, Impacted
Keywords: Interceptive orthodontics
maxillary canines
maxillary expansion
Tooth extraction
deciduous tooth
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 84
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: The detailed information regarding methodology has been entered in following sections

Eligibility criteria: 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

Primary outcomes:
measure: Number of Definitive Upper Canines That Erupt Spontaneously up to 18 Months of Follow up
timeFrame: 18 months
measure: Number of Definitive Upper Canines That Erupt Spontaneously After 18 Months of Follow up
timeFrame: After the first 18 months of follow up
Secondary outcomes:
measure: Sector Where the Canine is Located
timeFrame: 18 months
measure: Angulation of the Canine Towards the Dental Midline
timeFrame: 18 months
measure: Angulation of the Canine Towards the First Premolar
timeFrame: 18 months
measure: Distance Between the Canine Cusp and the Midline
timeFrame: 18 months
measure: Distance Between the Canine Cusp and the Occlusal Plane
timeFrame: 18 months
measure: Need for Further Minor and/or Major Orthodontic Intervention
timeFrame: 18 months after baseline
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
Study officials:
affiliation: UZ Leuven
name: Maria Cadenas
role: PRINCIPAL_INVESTIGATOR
References: