Trial Outcomes & Findings for Effect of Interceptive Strategies on the Clinical Outcome of Maxillary Impacted Canines (NCT NCT05629312)
NCT ID: NCT05629312
Last Updated: 2025-03-26
Results Overview
Number of definitive upper canines that erupt spontaneously up to 18 months of follow up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
18 months
Results posted on
2025-03-26
Participant Flow
Participant milestones
| Measure |
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
Maxillary expansion: The upper jaw is expanded with a removable expansion plate
|
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
Extraction of deciduous upper canines: Both deciduous upper canines are extracted in this group
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
18
|
16
|
28
|
|
Overall Study
COMPLETED
|
19
|
17
|
14
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Interceptive Strategies on the Clinical Outcome of Maxillary Impacted Canines
Baseline characteristics by cohort
| Measure |
Maxillary Expansion
n=19 Participants
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
Maxillary expansion: The upper jaw is expanded with a removable expansion plate
|
Extraction of Deciduous Canines
n=17 Participants
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
Extraction of deciduous upper canines: Both deciduous upper canines are extracted in this group
|
No Intervention
n=14 Participants
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
|
Control
n=26 Participants
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
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
8.9 years
STANDARD_DEVIATION 1.16 • n=5 Participants
|
9.1 years
STANDARD_DEVIATION 1.46 • n=7 Participants
|
9.0 years
STANDARD_DEVIATION 1.23 • n=5 Participants
|
9.7 years
STANDARD_DEVIATION 1.44 • n=4 Participants
|
9.2 years
STANDARD_DEVIATION 1.32 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: This outcome measure (number 1) analyzes the amount of maxillary canines that have erupted per studied group within 18 months of the start of trial. Each included participant has two upper canines, all of them were analyzed. The Outcome Measure Data Table describes how many erupted after 18 months from all analyzed canines.
Number of definitive upper canines that erupt spontaneously up to 18 months of follow up.
Outcome measures
| Measure |
Maxillary Expansion
n=38 number of upper canine teeth
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
Maxillary expansion: The upper jaw is expanded with a removable expansion plate
|
Extraction of Deciduous Canines
n=34 number of upper canine teeth
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
Extraction of deciduous upper canines: Both deciduous upper canines are extracted in this group
|
No Intervention
n=28 number of upper canine teeth
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
|
Control
n=52 number of upper canine teeth
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
|
|---|---|---|---|---|
|
Number of Definitive Upper Canines That Erupt Spontaneously up to 18 Months of Follow up
|
3 number of canines
|
2 number of canines
|
1 number of canines
|
4 number of canines
|
PRIMARY outcome
Timeframe: After the first 18 months of follow upPopulation: This outcome measure (number 2) analyzes the amount of maxillary canines that have erupted per studied group after 18 months of the start of trial. Each included participant has two upper canines, all of them were analyzed. The Outcome Measure Data Table describes how many erupted after 18 months from all analyzed canines.
Number of definitive upper canines that erupt spontaneously after 18 months of follow up..
Outcome measures
| Measure |
Maxillary Expansion
n=38 number of upper canine teeth
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
Maxillary expansion: The upper jaw is expanded with a removable expansion plate
|
Extraction of Deciduous Canines
n=34 number of upper canine teeth
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
Extraction of deciduous upper canines: Both deciduous upper canines are extracted in this group
|
No Intervention
n=28 number of upper canine teeth
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
|
Control
n=52 number of upper canine teeth
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
|
|---|---|---|---|---|
|
Number of Definitive Upper Canines That Erupt Spontaneously After 18 Months of Follow up
|
4 number of canines
|
4 number of canines
|
6 number of canines
|
15 number of canines
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Mean change in sector unit (where the canine is located) during the study period (18 months) per group
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
Outcome measures
| Measure |
Maxillary Expansion
n=38 sector where the canine is located
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
Maxillary expansion: The upper jaw is expanded with a removable expansion plate
|
Extraction of Deciduous Canines
n=34 sector where the canine is located
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
Extraction of deciduous upper canines: Both deciduous upper canines are extracted in this group
|
No Intervention
n=28 sector where the canine is located
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
|
Control
n=52 sector where the canine is located
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
|
|---|---|---|---|---|
|
Sector Where the Canine is Located
|
-0.22 Change in sector unit
Interval -0.43 to -0.01
|
-0.15 Change in sector unit
Interval -0.33 to 0.03
|
0.11 Change in sector unit
Interval -0.22 to 0.43
|
-0.10 Change in sector unit
Interval -0.23 to 0.02
|
SECONDARY outcome
Timeframe: 18 monthsChange in the Angulation of the canine towards the dental midline, measured on a panoramic RX
Outcome measures
| Measure |
Maxillary Expansion
n=38 Upper canine teeth
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
Maxillary expansion: The upper jaw is expanded with a removable expansion plate
|
Extraction of Deciduous Canines
n=34 Upper canine teeth
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
Extraction of deciduous upper canines: Both deciduous upper canines are extracted in this group
|
No Intervention
n=28 Upper canine teeth
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
|
Control
n=52 Upper canine teeth
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
|
|---|---|---|---|---|
|
Angulation of the Canine Towards the Dental Midline
|
-11.85 Degrees
Interval -15.99 to -7.71
|
-8.16 Degrees
Interval -13.19 to -3.13
|
-7.68 Degrees
Interval -13.76 to -1.6
|
-11.29 Degrees
Interval -15.06 to -7.52
|
SECONDARY outcome
Timeframe: 18 monthsChange in the Angulation of the canine towards the first premolar
Outcome measures
| Measure |
Maxillary Expansion
n=38 Upper canine teeth
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
Maxillary expansion: The upper jaw is expanded with a removable expansion plate
|
Extraction of Deciduous Canines
n=34 Upper canine teeth
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
Extraction of deciduous upper canines: Both deciduous upper canines are extracted in this group
|
No Intervention
n=28 Upper canine teeth
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
|
Control
n=52 Upper canine teeth
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
|
|---|---|---|---|---|
|
Angulation of the Canine Towards the First Premolar
|
-2.27 Degrees
Interval -5.92 to 1.38
|
-3.13 Degrees
Interval -6.78 to 0.53
|
0.08 Degrees
Interval -4.7 to 4.86
|
-2.57 Degrees
Interval -6.88 to 1.73
|
SECONDARY outcome
Timeframe: 18 monthsChange in the Distance between the canine cusp and the midline
Outcome measures
| Measure |
Maxillary Expansion
n=38 Upper canine teeth cusp
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
Maxillary expansion: The upper jaw is expanded with a removable expansion plate
|
Extraction of Deciduous Canines
n=34 Upper canine teeth cusp
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
Extraction of deciduous upper canines: Both deciduous upper canines are extracted in this group
|
No Intervention
n=28 Upper canine teeth cusp
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
|
Control
n=52 Upper canine teeth cusp
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
|
|---|---|---|---|---|
|
Distance Between the Canine Cusp and the Midline
|
0.83 millimeters
Interval -0.58 to 2.24
|
0.57 millimeters
Interval -0.65 to 1.8
|
-0.51 millimeters
Interval -2.21 to 1.19
|
1.77 millimeters
Interval 0.14 to 3.41
|
SECONDARY outcome
Timeframe: 18 monthsChenge in the Distance between the canine cusp and the occlusal plane, measured on a
Outcome measures
| Measure |
Maxillary Expansion
n=38 Upper canine teeth cusp
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
Maxillary expansion: The upper jaw is expanded with a removable expansion plate
|
Extraction of Deciduous Canines
n=34 Upper canine teeth cusp
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
Extraction of deciduous upper canines: Both deciduous upper canines are extracted in this group
|
No Intervention
n=28 Upper canine teeth cusp
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
|
Control
n=52 Upper canine teeth cusp
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
|
|---|---|---|---|---|
|
Distance Between the Canine Cusp and the Occlusal Plane
|
-6.31 millimeters
Interval -9.82 to -2.8
|
-4.79 millimeters
Interval -6.87 to -2.71
|
-7.10 millimeters
Interval -10.78 to -3.43
|
-9.14 millimeters
Interval -11.78 to -6.51
|
SECONDARY outcome
Timeframe: 18 months after baselineNeed for further minor and/or major orthodontic interventions
Outcome measures
| Measure |
Maxillary Expansion
n=19 Participants
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
Maxillary expansion: The upper jaw is expanded with a removable expansion plate
|
Extraction of Deciduous Canines
n=17 Participants
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
Extraction of deciduous upper canines: Both deciduous upper canines are extracted in this group
|
No Intervention
n=14 Participants
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
|
Control
n=26 Participants
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
|
|---|---|---|---|---|
|
Need for Further Minor and/or Major Orthodontic Intervention
Minor intervention
|
8 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
|
Need for Further Minor and/or Major Orthodontic Intervention
MAjor intervention
|
4 Participants
|
9 Participants
|
7 Participants
|
2 Participants
|
Adverse Events
Maxillary Expansion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Extraction of Deciduous Canines
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place