An interventional study of Interceptive Slow Maxillary Expansion with removable plates in Tooth Impaction and Canine Teeth, sponsored by Universitaire Ziekenhuizen KU Leuven. Active, not recruiting at 3 sites in 3 countries. Open to participants aged 7 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Treatment
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.
122 studies on the registry are indexed under Tooth, Impacted; 15 are open to participants now.
This study's planned enrollment of 75 is close to the median of 70 across 88 interventional studies indexed under Tooth, Impacted.
Browse Tooth, Impacted studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
General inclusion criteria:
Exclusion Criteria:
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
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
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
Interceptive Slow Maxillary Expansion with removable plates (see Willems et al 2023) https://doi.org/10.1093/ejo/cjad014
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
Time frame: 18 months
Need for subsequent interventions (extraction of deciduous or permanent teeth, other orthodontic interventions, surgical exposure)
Need for subsequent interventions (extraction of deciduous or permanent teeth, other orthodontic interventions, surgical exposure)
Time frame: 18 months
Plan to share: No
Started Oct 2024 (actual). Primary completion is estimated for Aug 2026, 21 months after the start.
Of 55 non-industry interventional studies with no phase under Tooth, Impacted, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's planned 21 months is close to that.
Counting every sponsor, half of 56 studies reached it within 20 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universitaire Ziekenhuizen KU Leuven →