About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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 design
Parallel
Treatments tested in this trial
The novel surgical method
Procedure/SurgeryAdditional bone removal in intended direction for tooth movement
The conventional surgical method
Procedure/SurgeryThe conventional method to use surgery
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Other outcomes
Patient-reported pain and discomfort
Patient-reported outcomes such as pain and discomfort during the treatment process will also be assessed using standardized questionnaires.
Sponsors and contacts
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Malmö University
Lead sponsor
Ortodontilund AB
Collaborator