Clinical Trial

Comparing a Novel Closed Exposure Technique to a Conventional Method for Palatally Impacted Maxillary Canines

Study acronym: PDC
Recruiting
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Record status
This record was last updated May 11, 2025 (before its estimated January 10, 2026 completion). Its status may not reflect the trial's current state.
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. 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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-02-17; most recent amendment 2025-05-09.
Status change: Not Yet Recruiting → Recruiting 2025-05-09
Trial Details
NCT Number NCT06833034
Lead Sponsor Malmö University
Collaborators: Ortodontilund AB
Conditions Impacted Canines
Enrollment 66 participants
Start Date 2025-03-07
Primary Completion 2026-01-10 (estimated)
Study Completion 2026-07-10 (estimated)
Updated on ClinicalTrials.gov 2025-05-11