Comparing a Novel Closed Exposure Technique to a Conventional Method for Palatally Impacted Maxillary Canines
NCT ID: NCT06833034
Last Updated: 2025-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2025-03-07
2026-07-10
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
QUADRUPLE
Study Groups
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The conventional surgical method
The conventional surgical method usually used in the clinic
The novel surgical method
Additional bone removal in intended direction for tooth movement
The novel surgical method
Additional bone removal in intendet direction of tooth movement
The conventional surgical method
The conventional method to use surgery
Interventions
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The novel surgical method
Additional bone removal in intended direction for tooth movement
The conventional surgical method
The conventional method to use surgery
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with earlier orthodontic treatment
* Patients with canines with angle \>45º (fig.1)
* Patients with canines with impacted canines in sectors 1 or 2
10 Months
18 Months
ALL
No
Sponsors
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Ortodontilund AB
OTHER
Malmö University
OTHER
Responsible Party
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Principal Investigators
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Mikael Sonesson, Docent
Role: STUDY_DIRECTOR
Malmö University
Locations
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Borgska villans specialisttandvård
Lund, Skåne County, Sweden
Malmö universitet
Malmo, Skåne County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Dnr 2023-02596-02
Identifier Type: -
Identifier Source: org_study_id
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