Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
The detailed information regarding methodology has been entered in following sections
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maxillary expansion | Experimental | 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 |
|
| Extraction of deciduous canines | Experimental | 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 |
|
| 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 | |
| Control | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maxillary expansion | Procedure | The upper jaw is expanded with a removable expansion plate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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.. | After the first 18 months of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maria Cadenas | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Vlaams Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37266982 | Derived | Willems G, Butaye C, Raes M, Zong C, Begnoni G, Cadenas de Llano-Perula M. Early prevention of maxillary canine impaction: a randomized clinical trial. Eur J Orthod. 2023 Jul 31;45(4):359-369. doi: 10.1093/ejo/cjad014. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Information not different to that of Participant Flow
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | number of canines | 18 months | number of upper canine teeth | number of upper canine teeth |
|
3 years (18 months during trial period, 18 months after trial period)
The interventions studies cannot cause mortality
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Maria Cadenas | UZLeuven | +3216332017 | maria.cadenas@uzleuven.be |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2016 | Nov 14, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D014095 | Tooth, Impacted |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010155 | Palatal Expansion Technique |
| ID | Term |
|---|---|
| D009971 | Orthodontics, Corrective |
| D009970 | Orthodontics |
| D003813 | Dentistry |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Extraction of deciduous upper canines | Procedure | Both deciduous upper canines are extracted in this group |
|
| 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 | 18 months |
| Angulation of the Canine Towards the First Premolar | Change in the Angulation of the canine towards the first premolar | 18 months |
| Distance Between the Canine Cusp and the Midline | Change in the Distance between the canine cusp and the midline | 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 | 18 months |
| Need for Further Minor and/or Major Orthodontic Intervention | Need for further minor and/or major orthodontic interventions | 18 months after baseline |
| 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Leuven, Belgium | Count of Participants | Participants |
|
| OG001 | 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 |
| OG002 | 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 |
| OG003 | 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 |
|
|
| 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.. | 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. | Posted | Number | number of canines | After the first 18 months of follow up | number of upper canine teeth | number of upper canine teeth |
|
|
|
| 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 | Mean change in sector unit (where the canine is located) during the study period (18 months) per group | Posted | Mean | 95% Confidence Interval | Change in sector unit | 18 months | sector where the canine is located | sector where the canine is located |
|
|
|
| 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 | Posted | Mean | 95% Confidence Interval | Degrees | 18 months | Upper canine teeth | Upper canine teeth |
|
|
|
| Secondary | Angulation of the Canine Towards the First Premolar | Change in the Angulation of the canine towards the first premolar | Posted | Mean | 95% Confidence Interval | Degrees | 18 months | Upper canine teeth | Upper canine teeth |
|
|
|
| Secondary | Distance Between the Canine Cusp and the Midline | Change in the Distance between the canine cusp and the midline | Posted | Mean | 95% Confidence Interval | millimeters | 18 months | Upper canine teeth cusp | Upper canine teeth cusp |
|
|
|
| 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 | Posted | Mean | 95% Confidence Interval | millimeters | 18 months | Upper canine teeth cusp | Upper canine teeth cusp |
|
|
|
| Secondary | Need for Further Minor and/or Major Orthodontic Intervention | Need for further minor and/or major orthodontic interventions | Posted | Count of Participants | Participants | 18 months after baseline |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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 | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | 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 | 0 | 14 | 0 | 14 | 0 | 14 |
| EG003 | 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 | 0 | 26 | 0 | 26 | 0 | 26 |
Not provided
Not provided
Not provided
| number of upper canine teeth |
|
| sector where the canine is located |
|
| Upper canine teeth |
|
| Upper canine teeth |
|
| Upper canine teeth cusp |
|
| Upper canine teeth cusp |
|
| MAjor intervention |
|