Tooth ImpactionRCTcanines2NCT06374329
Effect of Interceptive Strategies on the Clinical Outcome of Impacted Maxillary Permanent Canines
A study testing Interceptive Slow Maxillary Expansion with removable plates in people with Tooth Impaction and Canine Teeth, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in 3 countries.
Trial summary
Canine impaction is a sign of abnormal dental development with potentially far-reaching consequences (such as significant root resorption and loss of lateral incisors. This compromises both aesthetics and function of the teeth, making the prediction of canine tooth impaction increasingly important. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Impaction, Canine Teeth
- What is being tested?
- Interceptive Slow Maxillary Expansion with removable plates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 22 Oct 2024to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- General inclusion criteria:
- Female or male patients between 7.5 and 9.5 years-old coming to the department of Orthodontics of UZ Leuven (or one of the participating centres) seeking for orthodontic advice.
- Presenting with one or two impacted maxillary permanent canines, defined by 3¨ML between 15 and 45 degrees (If bilateral impaction occurs, categorization into the different protocol groups will be based on the canine showing the worst position).
- Presenting with one or two maxillary permanent canines showing no more than ¾ root formation, persisting deciduous canines and molars and lack of space in the maxillary arch, defined by ALD>0 mm
- Any race Inclusion criteria Group A: posterior crossbite Inclusion criteria Groups B and C: no posterior crossbite
Who cannot join
- Fully erupted permanent canines
- Previous orthodontic treatment.
- Canines with completed root formation
- Evidence of root resorption of adjacent teeth or root malformation of the canines that would obligate to extract any adjacent teeth or the canine(s).
- Craniofacial syndromes
- Systemic disease that would impede orthodontic treatment/surgery
- Recent exposure to radiotherapy.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Belgium1 site
University Hospitals Leuven - Service of Dentistry, Unit of Orthodontics
Leuven, 3000
Czechia1 site
Institute of Dentistry and Oral Sciences, Faculty of Medicine and Dentistry, Palacký University
Olomouc
About this study
Official title: Effect of Interceptive Strategies on the Clinical Outcome of Impacted Maxillary Permanent Canines - RCT Phase 2
Canine impaction is a sign of abnormal dental development with potentially far-reaching consequences (such as significant root resorption and loss of lateral incisors. This compromises both aesthetics and function of the teeth, making the prediction of canine tooth impaction increasingly important. Interceptive orthodontic measures, such as extraction of deciduous canines or molars or maxillary expansion aim to create extra space in the dental arch, allowing the canines to position themselves better and normalizing their eruption pattern.
This study corresponds to the second phase of an RCT, based on the results of the first phase, published in July 2023 (S59030) (Willems G, Butaye C, Raes M, Zong C, Begnoni G, Cadenas de Llano-Pérula M. Early prevention of maxillary canine impaction: a randomized clinical trial. Eur J Orthod. 31;45(4):359-369). The first phase compared the effect of 3 interceptive strategies (expansion, extraction and no intervention) on the position of impacted maxillary canines, finding that maxillary expansion provides the most improvement on impacted canine position. In second phase, 8-year-old patients without posterior crossbite and lack of space in the dental arch are randomized to treatment with 'slow maxillary expansion with removable plates' or 'no treatment'. These groups are additionally compared with patients with a crossbite and lack of space, which always receive expansion treatment. All selected patients will be followed up for at least 18 months. The primary endpoint is to investigate the effect of maxillary expansion with removable plates on the position of maxillary canines prone to impaction during early mixed dentition, assessed on panoramic X-rays. The secondary endpoint is the assessment of the need for additional orthodontic treatment.
- Conditions
- Tooth Impaction, Canine Teeth
- Being tested
- Interceptive Slow Maxillary Expansion with removable plates
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interceptive Slow Maxillary Expansion with removable platesOther
Interceptive Slow Maxillary Expansion with removable plates (see Willems et al 2023) https://doi.org/10.1093/ejo/cjad014
| Study group | Role | What they receive |
|---|---|---|
| Posterior crossbite and lack of space (Group A - Expansion) | Experimental | Patients with at least one impacted maxillary canine, uni or bilateral posterior crossbite and lack of space in the upper arch will be treated with slow maxillary expansion with removable plates (GROUP A - expansion) Receives: Other: Interceptive Slow Maxillary Expansion with removable plates |
| No Posterior crossbite and lack of space (Group B - Expansion) | Experimental | Patients with at least one impacted maxillary canine, no uni or bilateral posterior crossbite and lack of space in the upper arch will be treated with slow maxillary expansion with removable plates (GROUP B - expansion) .
Inclusion in groups B and C will be randomized Receives: Other: Interceptive Slow Maxillary Expansion with removable plates |
| No Posterior crossbite and lack of space (Group C - Expansion) | No intervention | Patients with at least one impacted maxillary canine, no uni or bilateral posterior crossbite and lack of space in the upper arch will receive no treatment and will be simply followed up (GROUP C - No intervention) Inclusion in groups B and C will be randomized |
What is being measured
The primary outcome is the main question the study is designed to answer.
Position of the impacted maxillary canine towards the dental midline (3^ML).
Longitudinal difference in the position of the impacted maxillary canine towards the dental midline (3^ML), measured radiologically on panoramic radiographs before the study and at 18 months follow up
Measured: 18 months
Secondary outcomes (1)
Need for subsequent interventions (extraction of deciduous or permanent teeth, other orthodontic interventions, surgical exposure)
Need for subsequent interventions (extraction of deciduous or permanent teeth, other orthodontic interventions, surgical exposure)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start22 Oct 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth ImpactionStudies 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
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, University of Copenhagen, Palacky University, The University of Hong Kong
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374329
- Sponsor's protocol ID
- S68717
- Acronym
- RCTcanines2
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Interceptive Strategies on the Clinical Outcome of Impacted Maxillary Permanent Canines - RCT Phase 2
- ClinicalTrials.gov ID
- NCT06374329
- Acronym / sponsor ID
- RCTcanines2 / S68717
- Conditions
- Tooth Impaction, Canine Teeth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Karolinska Institutet, University of Copenhagen, Palacky University, The University of Hong Kong
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Canine impaction is a sign of abnormal dental development with potentially far-reaching consequences (such as significant root resorption and loss of lateral incisors. This compromises both aesthetics and function of the teeth, making the prediction of canine tooth impaction increasingly important. Interceptive orthodontic measures, such as extraction of deciduous canines or molars or maxillary expansion aim to create extra space in the dental arch, allowing the canines to position themselves better and normalizing their eruption pattern.
This study corresponds to the second phase of an RCT, based on the results of the first phase, published in July 2023 (S59030) (Willems G, Butaye C, Raes M, Zong C, Begnoni G, Cadenas de Llano-Pérula M. Early prevention of maxillary canine impaction: a randomized clinical trial. Eur J Orthod. 31;45(4):359-369). The first phase compared the effect of 3 interceptive strategies (expansion, extraction and no intervention) on the position of impacted maxillary canines, finding that maxillary expansion provides the most improvement on impacted canine position. In second phase, 8-year-old patients without posterior crossbite and lack of space in the dental arch are randomized to treatment with 'slow maxillary expansion with removable plates' or 'no treatment'. These groups are additionally compared with patients with a crossbite and lack of space, which always receive expansion treatment. All selected patients will be followed up for at least 18 months. The primary endpoint is to investigate the effect of maxillary expansion with removable plates on the position of maxillary canines prone to impaction during early mixed dentition, assessed on panoramic X-rays. The secondary endpoint is the assessment of the need for additional orthodontic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Posterior crossbite and lack of space (Group A - Expansion) | Experimental | Other: Interceptive Slow Maxillary Expansion with removable platesPatients with at least one impacted maxillary canine, uni or bilateral posterior crossbite and lack of space in the upper arch will be treated with slow maxillary expansion with removable plates (GROUP A - expansion) |
| No Posterior crossbite and lack of space (Group B - Expansion) | Experimental | Other: Interceptive Slow Maxillary Expansion with removable platesPatients with at least one impacted maxillary canine, no uni or bilateral posterior crossbite and lack of space in the upper arch will be treated with slow maxillary expansion with removable plates (GROUP B - expansion) . Inclusion in groups B and C will be randomized |
| No Posterior crossbite and lack of space (Group C - Expansion) | No intervention | –Patients with at least one impacted maxillary canine, no uni or bilateral posterior crossbite and lack of space in the upper arch will receive no treatment and will be simply followed up (GROUP C - No intervention) Inclusion in groups B and C will be randomized |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Female or male patients between 7.5 and 9.5 years-old coming to the department of Orthodontics of UZ Leuven (or one of the participating centres) seeking for orthodontic advice.
- Presenting with one or two impacted maxillary permanent canines, defined by 3¨ML between 15 and 45 degrees (If bilateral impaction occurs, categorization into the different protocol groups will be based on the canine showing the worst position).
- Presenting with one or two maxillary permanent canines showing no more than ¾ root formation, persisting deciduous canines and molars and lack of space in the maxillary arch, defined by ALD>0 mm
- Any race Inclusion criteria Group A: posterior crossbite Inclusion criteria Groups B and C: no posterior crossbite
Key exclusion criteria (7 listed)
- Fully erupted permanent canines
- Previous orthodontic treatment.
- Canines with completed root formation
- Evidence of root resorption of adjacent teeth or root malformation of the canines that would obligate to extract any adjacent teeth or the canine(s).
- Craniofacial syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interceptive Slow Maxillary Expansion with removable platesInterceptive Slow Maxillary Expansion with removable plates (see Willems et al 2023) https://doi.org/10.1093/ejo/cjad014 | Other | No Posterior crossbite and lack of space (Group B - Expansion), Posterior crossbite and lack of space (Group A - Expansion) |
Primary outcome
Position of the impacted maxillary canine towards the dental midline (3^ML).
Time frame: 18 months
Longitudinal difference in the position of the impacted maxillary canine towards the dental midline (3^ML), measured radiologically on panoramic radiographs before the study and at 18 months follow up
1 secondary outcome
Need for subsequent interventions (extraction of deciduous or permanent teeth, other orthodontic interventions, surgical exposure)
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Results publication: PubMed 37266982Willems 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.
- Department of Oral Healths Sciences - Orthodontics University KU Leuven, BelgiumLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interceptive Slow Maxillary Expansion with removable plates in people with Tooth Impaction and Canine Teeth, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Czechia, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Position of the impacted maxillary canine towards the dental midline (3^ML). (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06374329, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.