Actively Recruiting

Phase Not Applicable
Age: 10Months - 18Months
All Genders
NCT06833034

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

Led by Malmö University · Updated on 2025-05-11

66

Participants Needed

2

Research Sites

70 weeks

Total Duration

On this page

Sponsors

M

Malmö University

Lead Sponsor

O

Ortodontilund AB

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 10Months - 18Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with palatally impacted maxillary canine on one side, in sector 2-4 and with angle <45º are included.
Not Eligible

You will not qualify if you...

  • Patients with clefts or syndromes
  • Patients with earlier orthodontic treatment
  • Patients with canines with angle >45º
  • Patients with impacted canines in sectors 1 or 2

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Borgska villans specialisttandvård

Lund, Skåne County, Sweden, 223 55

Not Yet Recruiting

2

Malmö universitet

Malmö, Skåne County, Sweden, 214 21

Actively Recruiting

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Research Team

M

Mikael Sonesson, Docent

CONTACT

K

Katja Hashemi Elses, PhD studnet

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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