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Recruiting Not applicable

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

NCT06833034 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2025-03-07
Last updated
2025-05-11

Condition(s) studied

Impacted Canines

Investigational drug(s) / intervention(s)

The novel surgical methodThe conventional surgical method

The novel surgical method: Additional bone removal in intended direction for tooth movement

The conventional surgical method: The conventional method to use surgery

Study 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.

Eligibility

Sex
ALL
Min age
10 Months
Max age
18 Months
Healthy volunteers
No
Inclusion Criteria: • Patients with palatally impacted maxillary canine on one side, in sector 2-4 and with angle \<45º are included. Exclusion Criteria: * 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

Primary outcome measure(s)

  • Treatment time for the canine to be exposed in the oral cavity — 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.

Trial sites (2)

FacilityCityRegionStatus
Borgska villans specialisttandvård Lund Skåne County Not Yet Recruiting
Malmö universitet Malmö Skåne County Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06833034 on ClinicalTrials.gov ↗ ← All trials in Sweden