Tooth, ImpactedNCT05629312
Effect of Interceptive Strategies on the Clinical Outcome of Maxillary Impacted Canines
A study testing Maxillary expansion and Extraction of deciduous upper canines in people with Tooth, Impacted, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth, Impacted
- What is being tested?
- Maxillary expansion and Extraction of deciduous upper canines
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Sep 2016to 30 Oct 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Tooth, Impacted
- Being tested
- Maxillary expansion, Extraction of deciduous upper canines
- Keywords
- Interceptive orthodontics, maxillary canines, maxillary expansion, Tooth extraction, deciduous tooth
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary expansionProcedure or surgery
The upper jaw is expanded with a removable expansion plate
Extraction of deciduous upper caninesProcedure or surgery
Both deciduous upper canines are extracted in this group
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: 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 Receives: 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 |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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..
Measured: After the first 18 months of follow up
Secondary outcomes (6)
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
Measured: 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
Measured: 18 months
Angulation of the Canine Towards the First Premolar
Change in the Angulation of the canine towards the first premolar
Measured: 18 months
Distance Between the Canine Cusp and the Midline
Change in the Distance between the canine cusp and the midline
Measured: 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
Measured: 18 months
Need for Further Minor and/or Major Orthodontic Intervention
Need for further minor and/or major orthodontic interventions
Measured: 18 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start12 Sep 2016
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth, ImpactedStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Cadenas, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629312
- Sponsor's protocol ID
- S59030
- Status last verified
- Dec 2023
- First submitted
- 16 Nov 2022
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37266982