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

Study Overview
=================
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

Official Title
-----------------
Effect of Interceptive Strategies on the Clinical Outcome of Maxillary Impacted Canines

Conditions
-----------------
Tooth, Impacted

Intervention / Treatment
-----------------
* Procedure: Maxillary expansion
* Procedure: Extraction of deciduous upper canines


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maxillary expansion<br>All included patients (in all arms) present (at least one) maxillary canine impaction. Patients in this arm present also lack of space in the upper jaw and are treated with maxillary expansion | Procedure: Maxillary expansion<br>* The upper jaw is expanded with a removable expansion plate<br>|
| Experimental: Extraction of deciduous canines<br>All included patients (in all arms) present (at least one) maxillary canine impaction. Patients in this arm present also lack of space in the upper jaw and are treated with extraction of deciduous canines | Procedure: Extraction of deciduous upper canines<br>* Both deciduous upper canines are extracted in this group<br>|
| No Intervention: No intervention<br>All included patients (in all arms) present (at least one) maxillary canine impaction. Patients in this arm present also lack of space in the upper jaw and no intervention is performed | |
| No Intervention: Control<br>All included patients (in all arms) present (at least one) maxillary canine impaction. Patients in this arm do not present lack of space in the upper jaw and no intervention is performed | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of definitive upper canines that erupt spontaneously up to 18 months of follow up | Spontaneous eruption of definitive upper canines | 18 months | 
| Number of definitive upper canines that erupt spontaneously after 18 months of follow up | Spontaneous eruption of definitive upper canines | After the first 18 months of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sector where the canine is located | Improvement of the Sector where the canine is located, measured on a panoramic RX | 18 months | 
| Angulation of the canine towards the dental midline | Improvement of the Angulation of the canine towards the dental midline, measured on a panoramic RX | 18 months | 
| Angulation of the canine towards the first premolar | Improvement of the Angulation of the canine towards the first premolar, measured on a | 18 months | 
| Distance between the canine cusp and the midline | Improvement of the Distance between the canine cusp and the midline, measured on a | 18 months | 
| Distance between the canine cusp and the occlusal plane | Improvement of the Distance between the canine cusp and the occlusal plane, measured on a | 18 months | 
| Need for further minor and/or major orthodontic intervention | Need for further minor and/or major orthodontic intervention | After 18 months of Follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interceptive orthodontics, maxillary canines, maxillary expansion, Tooth extraction, deciduous tooth