Tooth, Impacted
Conditions
Keywords
Interceptive orthodontics, maxillary canines, maxillary expansion, Tooth extraction, deciduous tooth
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
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
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Definitive Upper Canines That Erupt Spontaneously up to 18 Months of Follow up | 18 months | Number of definitive upper canines that erupt spontaneously up to 18 months of follow up. |
| Number of Definitive Upper Canines That Erupt Spontaneously After 18 Months of Follow up | After the first 18 months of follow up | Number of definitive upper canines that erupt spontaneously after 18 months of follow up.. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angulation of the Canine Towards the First Premolar | 18 months | Change in the Angulation of the canine towards the first premolar |
| Distance Between the Canine Cusp and the Midline | 18 months | Change in the Distance between the canine cusp and the midline |
| Sector Where the Canine is Located | 18 months | 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 |
| Need for Further Minor and/or Major Orthodontic Intervention | 18 months after baseline | Need for further minor and/or major orthodontic interventions |
| Distance Between the Canine Cusp and the Occlusal Plane | 18 months | Chenge in the Distance between the canine cusp and the occlusal plane, measured on a |
| Angulation of the Canine Towards the Dental Midline | 18 months | Change in the Angulation of the canine towards the dental midline, measured on a panoramic RX |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 19 |
| 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 | 17 |
| 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 | 14 |
| 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 | 26 |
| Total | 76 |
Baseline characteristics
| Characteristic | Total | Maxillary Expansion | Extraction of Deciduous Canines | No Intervention | Control |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 76 Participants | 19 Participants | 17 Participants | 14 Participants | 26 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.2 years STANDARD_DEVIATION 1.32 | 8.9 years STANDARD_DEVIATION 1.16 | 9.1 years STANDARD_DEVIATION 1.46 | 9.0 years STANDARD_DEVIATION 1.23 | 9.7 years STANDARD_DEVIATION 1.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 76 Participants | 19 Participants | 17 Participants | 14 Participants | 26 Participants |
| Region of Enrollment Belgium | 76 Participants | 19 Participants | 17 Participants | 14 Participants | 26 Participants |
| Sex: Female, Male Female | 30 Participants | 11 Participants | 8 Participants | 6 Participants | 5 Participants |
| Sex: Female, Male Male | 46 Participants | 8 Participants | 9 Participants | 8 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 17 | 0 / 14 | 0 / 26 |
| other Total, other adverse events | 0 / 19 | 0 / 17 | 0 / 14 | 0 / 26 |
| serious Total, serious adverse events | 0 / 19 | 0 / 17 | 0 / 14 | 0 / 26 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maxillary Expansion | Number of Definitive Upper Canines That Erupt Spontaneously After 18 Months of Follow up | 4 number of canines |
| Extraction of Deciduous Canines | Number of Definitive Upper Canines That Erupt Spontaneously After 18 Months of Follow up | 4 number of canines |
| No Intervention | Number of Definitive Upper Canines That Erupt Spontaneously After 18 Months of Follow up | 6 number of canines |
| Control | Number of Definitive Upper Canines That Erupt Spontaneously After 18 Months of Follow up | 15 number of canines |
Primary
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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maxillary Expansion | Number of Definitive Upper Canines That Erupt Spontaneously up to 18 Months of Follow up | 3 number of canines |
| Extraction of Deciduous Canines | Number of Definitive Upper Canines That Erupt Spontaneously up to 18 Months of Follow up | 2 number of canines |
| No Intervention | Number of Definitive Upper Canines That Erupt Spontaneously up to 18 Months of Follow up | 1 number of canines |
| Control | Number of Definitive Upper Canines That Erupt Spontaneously up to 18 Months of Follow up | 4 number of canines |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maxillary Expansion | Angulation of the Canine Towards the Dental Midline | -11.85 Degrees |
| Extraction of Deciduous Canines | Angulation of the Canine Towards the Dental Midline | -8.16 Degrees |
| No Intervention | Angulation of the Canine Towards the Dental Midline | -7.68 Degrees |
| Control | Angulation of the Canine Towards the Dental Midline | -11.29 Degrees |
Secondary
Angulation of the Canine Towards the First Premolar
Change in the Angulation of the canine towards the first premolar
Time frame: 18 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maxillary Expansion | Angulation of the Canine Towards the First Premolar | -2.27 Degrees |
| Extraction of Deciduous Canines | Angulation of the Canine Towards the First Premolar | -3.13 Degrees |
| No Intervention | Angulation of the Canine Towards the First Premolar | 0.08 Degrees |
| Control | Angulation of the Canine Towards the First Premolar | -2.57 Degrees |
Secondary
Distance Between the Canine Cusp and the Midline
Change in the Distance between the canine cusp and the midline
Time frame: 18 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maxillary Expansion | Distance Between the Canine Cusp and the Midline | 0.83 millimeters |
| Extraction of Deciduous Canines | Distance Between the Canine Cusp and the Midline | 0.57 millimeters |
| No Intervention | Distance Between the Canine Cusp and the Midline | -0.51 millimeters |
| Control | Distance Between the Canine Cusp and the Midline | 1.77 millimeters |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maxillary Expansion | Distance Between the Canine Cusp and the Occlusal Plane | -6.31 millimeters |
| Extraction of Deciduous Canines | Distance Between the Canine Cusp and the Occlusal Plane | -4.79 millimeters |
| No Intervention | Distance Between the Canine Cusp and the Occlusal Plane | -7.10 millimeters |
| Control | Distance Between the Canine Cusp and the Occlusal Plane | -9.14 millimeters |
Secondary
Need for Further Minor and/or Major Orthodontic Intervention
Need for further minor and/or major orthodontic interventions
Time frame: 18 months after baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Maxillary Expansion | Need for Further Minor and/or Major Orthodontic Intervention | MAjor intervention | 4 Participants |
| Maxillary Expansion | Need for Further Minor and/or Major Orthodontic Intervention | Minor intervention | 8 Participants |
| Extraction of Deciduous Canines | Need for Further Minor and/or Major Orthodontic Intervention | MAjor intervention | 9 Participants |
| Extraction of Deciduous Canines | Need for Further Minor and/or Major Orthodontic Intervention | Minor intervention | 2 Participants |
| No Intervention | Need for Further Minor and/or Major Orthodontic Intervention | Minor intervention | 0 Participants |
| No Intervention | Need for Further Minor and/or Major Orthodontic Intervention | MAjor intervention | 7 Participants |
| Control | Need for Further Minor and/or Major Orthodontic Intervention | MAjor intervention | 2 Participants |
| Control | Need for Further Minor and/or Major Orthodontic Intervention | Minor intervention | 5 Participants |
Secondary
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
Population: Mean change in sector unit (where the canine is located) during the study period (18 months) per group
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maxillary Expansion | Sector Where the Canine is Located | -0.22 Change in sector unit |
| Extraction of Deciduous Canines | Sector Where the Canine is Located | -0.15 Change in sector unit |
| No Intervention | Sector Where the Canine is Located | 0.11 Change in sector unit |
| Control | Sector Where the Canine is Located | -0.10 Change in sector unit |