CompletedNCT05629312Updated Mar 26, 2025Results posted

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

An interventional study of Maxillary expansion and Extraction of deciduous upper canines in Tooth, Impacted, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 7 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-26.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 6 years 2 months after the study started (first participant enrolled Sep 2016, registered Nov 2022).

Phase: Not applicable
Study type: Interventional
Enrollment: 84
Allocation: Randomized
Ages: 7 Years to 11 Years
Sex: All

Study 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).

Read the detailed description

The detailed information regarding methodology has been entered in following sections

Conditions studied

Tooth, Impacted

Browse trials for

Tooth, Impacted 122

Keywords

Interceptive orthodontics
maxillary canines
maxillary expansion
Tooth extraction
deciduous tooth

In context

Tooth, Impacted

122 studies on the registry are indexed under Tooth, Impacted; 15 are open to participants now.

This study's enrollment of 84 is above the median of 70 across 88 interventional studies indexed under Tooth, Impacted.

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Lead sponsor

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.

Browse Universitaire Ziekenhuizen KU Leuven studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 7 Years to 11 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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.

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 84 participants (actual)

Study arms

Experimental
Maxillary expansion
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
Experimental
Extraction of deciduous canines
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
No intervention
No intervention
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
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

Interventions

ProcedureMaxillary expansion
The upper jaw is expanded with a removable expansion plate
ProcedureExtraction of deciduous upper canines
Both deciduous upper canines are extracted in this group

What researchers measure

Primary outcomes

Number of Definitive Upper Canines That Erupt Spontaneously up to 18 Months of Follow up
Number of definitive upper canines that erupt spontaneously up to 18 months of follow up.
Time frame: 18 months
Number of Definitive Upper Canines That Erupt Spontaneously After 18 Months of Follow up
Number of definitive upper canines that erupt spontaneously after 18 months of follow up..
Time frame: After the first 18 months of follow up

Secondary outcomes

Sector Where the Canine is Located
The sector is the position where the canine overlaps with adjacent teeth in a panoramic radiograph. The distance between the dental midline and the premolars is divided in 5 equally large spaces (units or categories 0 to 4) defined as follows: 0 = normal position (the cusp of the definitive canine is at the primary canine), 1 = distal to the long axis of the lateral incisor, 2 = mesial to the long axis of the lateral incisor, 3 = distal to the long axis of the central incisor, or 4 = mesial to the long axis of the central incisor This outcome measurement refers to the change in the Sector category where the canine is located, measured on a panoramic RX
Time frame: 18 months
Angulation of the Canine Towards the Dental Midline
Change in the Angulation of the canine towards the dental midline, measured on a panoramic RX
Time frame: 18 months
Angulation of the Canine Towards the First Premolar
Change in the Angulation of the canine towards the first premolar
Time frame: 18 months
Distance Between the Canine Cusp and the Midline
Change in the Distance between the canine cusp and the midline
Time frame: 18 months
Distance Between the Canine Cusp and the Occlusal Plane
Chenge in the Distance between the canine cusp and the occlusal plane, measured on a
Time frame: 18 months
Need for Further Minor and/or Major Orthodontic Intervention
Need for further minor and/or major orthodontic interventions
Time frame: 18 months after baseline

Results

Posted Mar 26, 2025

Participant flow

Participant flow — Overall Study
Milestone	Maxillary Expansion	Extraction of Deciduous Canines	No Intervention	Control
Started	22	18	16	28
Completed	19	17	14	26
Not completed	3	1	2	2

Outcome measures

PrimaryNumber of Definitive Upper Canines That Erupt Spontaneously up to 18 Months of Follow up

Number of definitive upper canines that erupt spontaneously up to 18 months of follow up.

Time frame:: 18 months
Reported as:: Number · number of canines

Number of Definitive Upper Canines That Erupt Spontaneously up to 18 Months of Follow up
number of canines	Maxillary Expansion	Extraction of Deciduous Canines	No Intervention	Control
Number of Definitive Upper Canines That Erupt Spontaneously up to 18 Months of Follow up	3	2	1	4

PrimaryNumber of Definitive Upper Canines That Erupt Spontaneously After 18 Months of Follow up

Number of definitive upper canines that erupt spontaneously after 18 months of follow up..

Time frame:: After the first 18 months of follow up
Reported as:: Number · number of canines

Number of Definitive Upper Canines That Erupt Spontaneously After 18 Months of Follow up
number of canines	Maxillary Expansion	Extraction of Deciduous Canines	No Intervention	Control
Number of Definitive Upper Canines That Erupt Spontaneously After 18 Months of Follow up	4	4	6	15

SecondarySector Where the Canine is Located

The sector is the position where the canine overlaps with adjacent teeth in a panoramic radiograph. The distance between the dental midline and the premolars is divided in 5 equally large spaces (units or categories 0 to 4) defined as follows: 0 = normal position (the cusp of the definitive canine is at the primary canine), 1 = distal to the long axis of the lateral incisor, 2 = mesial to the long axis of the lateral incisor, 3 = distal to the long axis of the central incisor, or 4 = mesial to the long axis of the central incisor This outcome measurement refers to the change in the Sector category where the canine is located, measured on a panoramic RX

Time frame:: 18 months
Reported as:: Mean · Change in sector unit

Sector Where the Canine is Located
Change in sector unit	Maxillary Expansion	Extraction of Deciduous Canines	No Intervention	Control
Sector Where the Canine is Located	-0.22 (-0.43 to -0.01)	-0.15 (-0.33 to 0.03)	0.11 (-0.22 to 0.43)	-0.10 (-0.23 to 0.02)

SecondaryAngulation of the Canine Towards the Dental Midline

Change in the Angulation of the canine towards the dental midline, measured on a panoramic RX

Time frame:: 18 months
Reported as:: Mean · Degrees

Angulation of the Canine Towards the Dental Midline
Degrees	Maxillary Expansion	Extraction of Deciduous Canines	No Intervention	Control
Angulation of the Canine Towards the Dental Midline	-11.85 (-15.99 to -7.71)	-8.16 (-13.19 to -3.13)	-7.68 (-13.76 to -1.60)	-11.29 (-15.06 to -7.52)

SecondaryAngulation of the Canine Towards the First Premolar

Change in the Angulation of the canine towards the first premolar

Time frame:: 18 months
Reported as:: Mean · Degrees

Angulation of the Canine Towards the First Premolar
Degrees	Maxillary Expansion	Extraction of Deciduous Canines	No Intervention	Control
Angulation of the Canine Towards the First Premolar	-2.27 (-5.92 to 1.38)	-3.13 (-6.78 to 0.53)	0.08 (-4.70 to 4.86)	-2.57 (-6.88 to 1.73)

SecondaryDistance Between the Canine Cusp and the Midline

Change in the Distance between the canine cusp and the midline

Time frame:: 18 months
Reported as:: Mean · millimeters

Distance Between the Canine Cusp and the Midline
millimeters	Maxillary Expansion	Extraction of Deciduous Canines	No Intervention	Control
Distance Between the Canine Cusp and the Midline	0.83 (-0.58 to 2.24)	0.57 (-0.65 to 1.80)	-0.51 (-2.21 to 1.19)	1.77 (0.14 to 3.41)

SecondaryDistance Between the Canine Cusp and the Occlusal Plane

Chenge in the Distance between the canine cusp and the occlusal plane, measured on a

Time frame:: 18 months
Reported as:: Mean · millimeters

Distance Between the Canine Cusp and the Occlusal Plane
millimeters	Maxillary Expansion	Extraction of Deciduous Canines	No Intervention	Control
Distance Between the Canine Cusp and the Occlusal Plane	-6.31 (-9.82 to -2.80)	-4.79 (-6.87 to -2.71)	-7.10 (-10.78 to -3.43)	-9.14 (-11.78 to -6.51)

SecondaryNeed for Further Minor and/or Major Orthodontic Intervention

Need for further minor and/or major orthodontic interventions

Time frame:: 18 months after baseline
Reported as:: Count of participants · Participants

Need for Further Minor and/or Major Orthodontic Intervention
Participants	Maxillary Expansion	Extraction of Deciduous Canines	No Intervention	Control
Minor intervention	8	2	0	5
MAjor intervention	4	9	7	2

Adverse events

Collected over 3 years (18 months during trial period, 18 months after trial period). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Maxillary Expansion	0/19 (0%)	0/19 (0%)	0/19 (0%)
Extraction of Deciduous Canines	0/17 (0%)	0/17 (0%)	0/17 (0%)
No Intervention	0/14 (0%)	0/14 (0%)	0/14 (0%)
Control	0/26 (0%)	0/26 (0%)	0/26 (0%)

Baseline characteristics

Information not different to that of Participant Flow

Age, Categorical
Age, Categorical(Participants)	Maxillary Expansion	Extraction of Deciduous Canines	No Intervention	Control	Total
<=18 years	19	17	14	26	76
Between 18 and 65 years	0	0	0	0	0
>=65 years	0	0	0	0	0

Age, Continuous
Age, Continuous(years)	Maxillary Expansion	Extraction of Deciduous Canines	No Intervention	Control	Total
Mean	8.9 ± 1.16	9.1 ± 1.46	9.0 ± 1.23	9.7 ± 1.44	9.2 ± 1.32

Sex: Female, Male
Sex: Female, Male(Participants)	Maxillary Expansion	Extraction of Deciduous Canines	No Intervention	Control	Total
Female	11	8	6	5	30
Male	8	9	8	21	46

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Maxillary Expansion	Extraction of Deciduous Canines	No Intervention	Control	Total
Hispanic or Latino	0	0	0	0	0
Not Hispanic or Latino	0	0	0	0	0
Unknown or Not Reported	19	17	14	26	76

Region of Enrollment
Region of Enrollment(Participants)	Maxillary Expansion	Extraction of Deciduous Canines	No Intervention	Control	Total
Belgium	19	17	14	26	76

Study locations

1 site

UZ Leuven
Leuven, Vlaams Brabant 3000, Belgium

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Jul 1, 2016

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2016 to primary completion in Oct 2023, 85 months.

Results were first posted in Mar 2025, 1 year 4 months after primary completion.

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 85 months is above 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.

Registered: Nov 16, 2022
First posted: Nov 29, 2022
StartActual: Sep 12, 2016
Primary completionActual: Oct 30, 2023
CompletionActual: Oct 30, 2023
Results first posted: Mar 26, 2025
Last update: Mar 26, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05629312
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Responsible party: Sponsor
First posted: Nov 29, 2022
Start date: Sep 12, 2016
Primary completion: Oct 30, 2023
Completion: Oct 30, 2023
Results posted: Mar 26, 2025
Last update: Mar 26, 2025

Study contacts

Maria Cadenas

principal investigator · UZ Leuven

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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