Impacted CaninesPDCNCT06833034
Comparing a Novel Closed Exposure Technique to a Conventional Method for Palatally Impacted Maxillary Canines
A study testing The novel surgical method and The conventional surgical method in people with Impacted Canines, run by Malmö University at 2 sites in Sweden.
Trial summary
A multi-center Randomized Clinical Trial, (RCT) on treatment effectiveness of two different closed surgical exposure techniques, one including additional bone removal and a second conventional without removal of additional bone, during treatment of palatally impacted maxillary canines. Read more about this study
- Who is it for?
- Ages 10 to 18 months
- Conditions the study is for
- Impacted Canines
- What is being tested?
- The novel surgical method and The conventional surgical method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesSweden
- Study dates
- 7 Mar 2025to 10 Jul 2026
- 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 10 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with palatally impacted maxillary canine on one side, in sector 2-4 and with angle <45º are included.
Who cannot join
- Patients with clefts or syndromes
- Patients with earlier orthodontic treatment
- Patients with canines with angle >45º (fig.1)
- Patients with canines with impacted canines in sectors 1 or 2
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Not yet recruiting
Borgska villans specialisttandvård
Lund, Skåne County, 223 55
- Recruiting
Malmö universitet
Malmö, Skåne County, 214 21
Mikael Sonesson, Docent, +46406658447, mikael.sonesson@mau.se
Katja Hashemi Elses, PHD student, +46464600130, katja.hashemi-elses@mau.se
About this study
Official title: To Compare the Effectiveness of a Novel Closed Exposure Technique With Removal of Bone Tissue and a Conventional Technique During Treatment of Palatally Impacted Maxillary Canines by Closed Surgical Exposure and Fixed Orthodontic Appliance
A multi-center Randomized Clinical Trial, (RCT) on treatment effectiveness of two different closed surgical exposure techniques, one including additional bone removal and a second conventional without removal of additional bone, during treatment of palatally impacted maxillary canines.
A comparison between the two methods regarding the anchorage situation for the incisors will be performed as well.
Read more
Introduction Surgical exposure of impacted maxillary canines together with orthodontic treatment has long been advocated. Closed exposure with placement of an auxiliary attachment with a chain, followed by traction of the canine with orthodontic forces is commonly clinical used to avoid complications with the open procedure (Kokich 2004). Both open and closed methods and orthodontic treatment are one of the most time-consuming orthodontic treatments. Therefore, it is valuable to try to find methods which can reduce the total treatment time and make the treatments as comfortable as possible for the patient.
To reduce the treatment time, study I investigates a novel strategy for traction of the canine. Another strategy to reduce the treatment time might be to facilitate the movement of the canine by additional bone removal in the eruption direction out to the alveolar crest. This has been used of a few orthodontists in one clinic for some years. No negative side-effects have been seen. There are, however, no studies for comparison of the two techniques.
Aim The primary aims of this Randomized Clinical Trial (RCT) is to evaluate the treatment effectiveness of two different surgical closed exposure techniques of palatally impacted canines before the orthodontic treatment; a) with removal of bone in traction direction and b) without removal of bone in traction direction and to evaluate the anchorage situations.
Outcome variables The outcome variables will be: 1) Treatment time for the canine to be exposed in the oral cavity; 2) Treatment time for the canine to be in the dental arch and 3) Treatment time for the canine to have reached the right position in the dental arch.
Subjects Sixty-six patients between 10-18- years, will be recruited to the study. Patients with palatally impacted maxillary canines are consecutively recruited at three orthodontic clinics in Lund, Karlshamn and Ängelholm.
Read the detailed description
Study Title: Comparing Novel and Conventional Techniques for Treating Palatally Impacted Maxillary Canines
Study Overview: This clinical study aims to compare the effectiveness and patient experiences of two different techniques used to treat palatally impacted maxillary canines. These are teeth that have not properly emerged into the mouth and are instead located in the palate. The study will focus on two specific techniques: a novel closed exposure technique that involves the removal of bone tissue, and a conventional traction technique.
Study Objectives:
Effectiveness and Patient Experience: The primary goal is to evaluate and compare the effectiveness of the novel and conventional techniques in treating palatally impacted maxillary canines. Additionally, the study will assess patient experiences, particularly focusing on pain and discomfort during the treatment process.
Anchorage Situation: The study will also compare the anchorage situation for the incisors (front teeth) when using the novel closed exposure technique versus the conventional technique.
Study Methods: Participants in the study will undergo treatment for their palatally impacted maxillary canines using either the novel closed exposure technique or the conventional traction technique. Both techniques involve closed surgical exposure and the use of fixed orthodontic appliances. Detailed descriptions of both techniques will be provided to ensure a clear understanding of the procedures.
Expected Outcomes: The study aims to determine which technique is more effective in treating palatally impacted maxillary canines and to understand the patient experiences associated with each technique. By comparing the two methods, the study hopes to provide valuable insights into the best practices for treating this dental condition.
Significance: Palatally impacted maxillary canines can cause significant dental issues if not properly treated. This study will contribute to the field of orthodontics by providing evidence-based recommendations for the most effective and comfortable treatment methods. The findings will help dental professionals make informed decisions and improve patient care.
- Conditions
- Impacted Canines
- Being tested
- The novel surgical method, The conventional surgical method
- Keywords
- impacted maxillary canines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The novel surgical methodProcedure or surgery
Additional bone removal in intended direction for tooth movement
The conventional surgical methodProcedure or surgery
The conventional method to use surgery
| Study group | Role | What they receive |
|---|---|---|
| The conventional surgical method | Active comparator | The conventional surgical method usually used in the clinic Receives: Procedure: The novel surgical method |
| The novel surgical method | Experimental | Additional bone removal in intendet direction of tooth movement Receives: Procedure: The conventional surgical method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment time for the canine to be exposed in the oral cavity
The primary outcome measure for this study is the treatment time required for the palatally impacted maxillary canine to be exposed in the oral cavity. This will be measured in months from the start of the treatment until the canine is visible.
Measured: 24 months
Secondary outcomes (1)
Treatment time for the canine to align and reach its final position
Secondary outcome measures include the treatment time for the canine to align within the dental arch and the time to reach its final position within the dental arch. This will be measured in months from the start of the treatment.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start7 Mar 2025
- Primary completion10 Jan 2026 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted CaninesStudies of the same condition, open and under way.
- 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
- Model description
- Surgical technique After anesthesia and rising of the mucoperiosteal flap the patients are randomized, by a staff member not involved in the study, for further treatment into one of two groups: A) The conventional surgical procedure without additional bone removal and B) the novel surgical procedure with additional bone removal. In the end of the surgical session, the auxiliary attachment is placed on the crown of the canine and the incision is made on the palatal flap letting the chain protrude exactly where the canine is placed. The flap is then sutured with conventional sutures and the patients are instructed to rinse with Chlorhexidine until the sutures are removed after 10 days at the orthodontic clinic and the chain is activated and followed as normal procedure in the orthodontic treatment. The surgery will be performed by one surgeon. The orthodontic treatment will be performed by four orthodontists at the three orthodontic clinics.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Collaborators
- Ortodontilund AB
- Responsible party
- Sponsor
- Investigators
- Mikael Sonesson, Docent, Study director, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833034
- Sponsor's protocol ID
- Dnr 2023-02596-02
- Acronym
- PDC
- Status last verified
- Mar 2025
- First submitted
- 12 Feb 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Effectiveness of a Novel Closed Exposure Technique With Removal of Bone Tissue and a Conventional Technique During Treatment of Palatally Impacted Maxillary Canines by Closed Surgical Exposure and Fixed Orthodontic Appliance
- ClinicalTrials.gov ID
- NCT06833034
- Acronym / sponsor ID
- PDC / Dnr 2023-02596-02
- Conditions
- Impacted Canines
- Keywords
- impacted maxillary canines
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Collaborators
- Ortodontilund AB
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 10 Jan 2026 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 18 Feb 2025 (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.
A multi-center Randomized Clinical Trial, (RCT) on treatment effectiveness of two different closed surgical exposure techniques, one including additional bone removal and a second conventional without removal of additional bone, during treatment of palatally impacted maxillary canines.
A comparison between the two methods regarding the anchorage situation for the incisors will be performed as well.
Introduction Surgical exposure of impacted maxillary canines together with orthodontic treatment has long been advocated. Closed exposure with placement of an auxiliary attachment with a chain, followed by traction of the canine with orthodontic forces is commonly clinical used to avoid complications with the open procedure (Kokich 2004). Both open and closed methods and orthodontic treatment are one of the most time-consuming orthodontic treatments. Therefore, it is valuable to try to find methods which can reduce the total treatment time and make the treatments as comfortable as possible for the patient.
To reduce the treatment time, study I investigates a novel strategy for traction of the canine. Another strategy to reduce the treatment time might be to facilitate the movement of the canine by additional bone removal in the eruption direction out to the alveolar crest. This has been used of a few orthodontists in one clinic for some years. No negative side-effects have been seen. There are, however, no studies for comparison of the two techniques.
Aim The primary aims of this Randomized Clinical Trial (RCT) is to evaluate the treatment effectiveness of two different surgical closed exposure techniques of palatally impacted canines before the orthodontic treatment; a) with removal of bone in traction direction and b) without removal of bone in traction direction and to evaluate the anchorage situations.
Outcome variables The outcome variables will be: 1) Treatment time for the canine to be exposed in the oral cavity; 2) Treatment time for the canine to be in the dental arch and 3) Treatment time for the canine to have reached the right position in the dental arch.
Subjects Sixty-six patients between 10-18- years, will be recruited to the study. Patients with palatally impacted maxillary canines are consecutively recruited at three orthodontic clinics in Lund, Karlshamn and Ängelholm.
Detailed description
Study Title: Comparing Novel and Conventional Techniques for Treating Palatally Impacted Maxillary Canines
Study Overview: This clinical study aims to compare the effectiveness and patient experiences of two different techniques used to treat palatally impacted maxillary canines. These are teeth that have not properly emerged into the mouth and are instead located in the palate. The study will focus on two specific techniques: a novel closed exposure technique that involves the removal of bone tissue, and a conventional traction technique.
Study Objectives:
Effectiveness and Patient Experience: The primary goal is to evaluate and compare the effectiveness of the novel and conventional techniques in treating palatally impacted maxillary canines. Additionally, the study will assess patient experiences, particularly focusing on pain and discomfort during the treatment process.
Anchorage Situation: The study will also compare the anchorage situation for the incisors (front teeth) when using the novel closed exposure technique versus the conventional technique.
Study Methods: Participants in the study will undergo treatment for their palatally impacted maxillary canines using either the novel closed exposure technique or the conventional traction technique. Both techniques involve closed surgical exposure and the use of fixed orthodontic appliances. Detailed descriptions of both techniques will be provided to ensure a clear understanding of the procedures.
Expected Outcomes: The study aims to determine which technique is more effective in treating palatally impacted maxillary canines and to understand the patient experiences associated with each technique. By comparing the two methods, the study hopes to provide valuable insights into the best practices for treating this dental condition.
Significance: Palatally impacted maxillary canines can cause significant dental issues if not properly treated. This study will contribute to the field of orthodontics by providing evidence-based recommendations for the most effective and comfortable treatment methods. The findings will help dental professionals make informed decisions and improve patient care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Surgical technique After anesthesia and rising of the mucoperiosteal flap the patients are randomized, by a staff member not involved in the study, for further treatment into one of two groups: A) The conventional surgical procedure without additional bone removal and B) the novel surgical procedure with additional bone removal. In the end of the surgical session, the auxiliary attachment is placed on the crown of the canine and the incision is made on the palatal flap letting the chain protrude exactly where the canine is placed. The flap is then sutured with conventional sutures and the patients are instructed to rinse with Chlorhexidine until the sutures are removed after 10 days at the orthodontic clinic and the chain is activated and followed as normal procedure in the orthodontic treatment. The surgery will be performed by one surgeon. The orthodontic treatment will be performed by four orthodontists at the three orthodontic clinics.
| Arm | Type | Receives |
|---|---|---|
| The conventional surgical method | Active comparator | Procedure: The novel surgical methodThe conventional surgical method usually used in the clinic |
| The novel surgical method | Experimental | Procedure: The conventional surgical methodAdditional bone removal in intendet direction of tooth movement |
Who may qualify
- Ages
- 10 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients with palatally impacted maxillary canine on one side, in sector 2-4 and with angle <45º are included.
Key exclusion criteria (4 listed)
- Patients with clefts or syndromes
- Patients with earlier orthodontic treatment
- Patients with canines with angle >45º (fig.1)
- Patients with canines with impacted canines in sectors 1 or 2
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 |
|---|---|---|
| The novel surgical methodAdditional bone removal in intended direction for tooth movement | Procedure or surgery | The conventional surgical method |
| The conventional surgical methodThe conventional method to use surgery | Procedure or surgery | The novel surgical method |
Primary outcome
Treatment time for the canine to be exposed in the oral cavity
Time frame: 24 months
The primary outcome measure for this study is the treatment time required for the palatally impacted maxillary canine to be exposed in the oral cavity. This will be measured in months from the start of the treatment until the canine is visible.
1 secondary outcome
Treatment time for the canine to align and reach its final position
Time frame: 24 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 11 May 2025.
- Individual participant dataSharing planned: No
Related trials for Impacted Canines
Enrolling by invitationObservational study
Accuracy of 3D Slicer Software for Automatic Segmentation Versus Manual Segmentation Using Commercial Software to Evaluate Impacted and Unerupted Maxillary Canine: An Observational Study
Impacted Canines
Active, not recruiting
Effect of Interceptive Strategies on the Clinical Outcome of Impacted Maxillary Permanent Canines
Tooth Impaction, Canine Teeth
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.
Mikael Sonesson, Docent study director
Malmö University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The novel surgical method and The conventional surgical method in people with Impacted Canines, run by Malmö University at 2 sites in Sweden.
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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Contact Mikael Sonesson, Docent (SWE: 040 665 84 47, mikael.sonesson@mau.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment time for the canine to be exposed in the oral cavity (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.