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

Primary Purpose

Tooth, Impacted

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Maxillary expansion
Extraction of deciduous upper canines
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth, Impacted focused on measuring Interceptive orthodontics, maxillary canines, maxillary expansion, Tooth extraction, deciduous tooth

Eligibility Criteria

7 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

No Intervention

Arm Label

Maxillary expansion

Extraction of deciduous canines

No intervention

Control

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Number of definitive upper canines that erupt spontaneously up to 18 months of follow up
Spontaneous eruption of definitive upper canines
Number of definitive upper canines that erupt spontaneously after 18 months of follow up
Spontaneous eruption of definitive upper canines

Secondary Outcome Measures

Sector where the canine is located
Improvement of the Sector where the canine is located, measured on a panoramic RX
Angulation of the canine towards the dental midline
Improvement of the Angulation of the canine towards the dental midline, measured on a panoramic RX
Angulation of the canine towards the first premolar
Improvement of the Angulation of the canine towards the first premolar, measured on a
Distance between the canine cusp and the midline
Improvement of the Distance between the canine cusp and the midline, measured on a
Distance between the canine cusp and the occlusal plane
Improvement of the Distance between the canine cusp and the occlusal plane, measured on a
Need for further minor and/or major orthodontic intervention
Need for further minor and/or major orthodontic intervention

Full Information

First Posted
November 16, 2022
Last Updated
November 28, 2022
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT05629312
Brief Title
Effect of Interceptive Strategies on the Clinical Outcome of Maxillary Impacted Canines
Official Title
Effect of Interceptive Strategies on the Clinical Outcome of Maxillary Impacted Canines
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2016 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth, Impacted
Keywords
Interceptive orthodontics, maxillary canines, maxillary expansion, Tooth extraction, deciduous tooth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maxillary expansion
Arm Type
Experimental
Arm Description
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
Arm Title
Extraction of deciduous canines
Arm Type
Experimental
Arm Description
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
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Maxillary expansion
Intervention Description
The upper jaw is expanded with a removable expansion plate
Intervention Type
Procedure
Intervention Name(s)
Extraction of deciduous upper canines
Intervention Description
Both deciduous upper canines are extracted in this group
Primary Outcome Measure Information:
Title
Number of definitive upper canines that erupt spontaneously up to 18 months of follow up
Description
Spontaneous eruption of definitive upper canines
Time Frame
18 months
Title
Number of definitive upper canines that erupt spontaneously after 18 months of follow up
Description
Spontaneous eruption of definitive upper canines
Time Frame
After the first 18 months of follow up
Secondary Outcome Measure Information:
Title
Sector where the canine is located
Description
Improvement of the Sector where the canine is located, measured on a panoramic RX
Time Frame
18 months
Title
Angulation of the canine towards the dental midline
Description
Improvement of the Angulation of the canine towards the dental midline, measured on a panoramic RX
Time Frame
18 months
Title
Angulation of the canine towards the first premolar
Description
Improvement of the Angulation of the canine towards the first premolar, measured on a
Time Frame
18 months
Title
Distance between the canine cusp and the midline
Description
Improvement of the Distance between the canine cusp and the midline, measured on a
Time Frame
18 months
Title
Distance between the canine cusp and the occlusal plane
Description
Improvement of the Distance between the canine cusp and the occlusal plane, measured on a
Time Frame
18 months
Title
Need for further minor and/or major orthodontic intervention
Description
Need for further minor and/or major orthodontic intervention
Time Frame
After 18 months of Follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guy Willems
Phone
+32 016 3332747
Email
guy.willems@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Cadenas
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy Willems
Phone
+32 016332747
Email
guy.willems@uzleuven.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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