Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06833034

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Impacted Canines

Age range

10 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Borgska villans specialisttandvård, Lund, Skåne County, Sweden

Loading trial locations.

About this study

Study Title: Comparing Novel and Conventional Techniques for Treating Palatally Impacted Maxillary Canines

Study Overview: This clinical study aims to compare the effectiveness and patient experiences of two different techniques used to treat palatally impacted maxillary canines. These are teeth that have not properly emerged into the mouth and are instead located in the palate. The study will focus on two specific techniques: a novel closed exposure technique that involves the removal of bone tissue, and a conventional traction technique.

Study Objectives:

Effectiveness and Patient Experience: The primary goal is to evaluate and compare the effectiveness of the novel and conventional techniques in treating palatally impacted maxillary canines. Additionally, the study will assess patient experiences, particularly focusing on pain and discomfort during the treatment process.

Anchorage Situation: The study will also compare the anchorage situation for the incisors (front teeth) when using the novel closed exposure technique versus the conventional technique.

Study Methods: Participants in the study will undergo treatment for their palatally impacted maxillary canines using either the novel closed exposure technique or the conventional traction technique. Both techniques involve closed surgical exposure and the use of fixed orthodontic appliances. Detailed descriptions of both techniques will be provided to ensure a clear understanding of the procedures.

Expected Outcomes: The study aims to determine which technique is more effective in treating palatally impacted maxillary canines and to understand the patient experiences associated with each technique. By comparing the two methods, the study hopes to provide valuable insights into the best practices for treating this dental condition.

Significance: Palatally impacted maxillary canines can cause significant dental issues if not properly treated. This study will contribute to the field of orthodontics by providing evidence-based recommendations for the most effective and comfortable treatment methods. The findings will help dental professionals make informed decisions and improve patient care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The novel surgical method

Procedure

Additional bone removal in intended direction for tooth movement

The conventional surgical method

Procedure

The conventional method to use surgery

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Treatment time for the canine to align and reach its final position

    Time frame: 24 months

    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

  1. Patient-reported pain and discomfort

    Time frame: 24 months

    Patient-reported outcomes such as pain and discomfort during the treatment process will also be assessed using standardized questionnaires.

Study contacts

Contact information is provided by the study sponsor or research team.

Katja Hashemi Elses, PhD studnet

CONTACT

[email protected]

+46705442505

Mikael Sonesson, Docent

CONTACT

[email protected]

SWE: 040 665 84 47

Sponsors and collaborators

Lead sponsor

Malmö University

Other

Collaborators

  • Ortodontilund AB

Registry information

Official study title

To Compare the Effectiveness of a Novel Closed Exposure Technique With Removal of Bone Tissue and a Conventional Technique During Treatment of Palatally Impacted Maxillary Canines by Closed Surgical Exposure and Fixed Orthodontic Appliance

Acronym: PDC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2025
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.