MedTrace Logo

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

NCT06833034 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-05-11

No results posted yet for this 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.

Conditions

  • Impacted Canines

Interventions

PROCEDURE

The novel surgical method

Additional bone removal in intended direction for tooth movement

PROCEDURE

The conventional surgical method

The conventional method to use surgery

Sponsors & Collaborators

  • Ortodontilund AB

    collaborator OTHER

  • Malmö University

    lead OTHER

Principal Investigators

  • Mikael Sonesson, Docent · Malmö University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-07
Primary Completion
2026-01-10
Completion
2026-07-10

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06833034 on ClinicalTrials.gov