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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Impacted Canines
• Intervention / Treatment: Procedure: The novel surgical method; Procedure: The conventional surgical method

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mikael Sonesson, Docent; Phone Number: SWE: 040 665 84 47; Email: mikael.sonesson@mau.se
• Study Contact Backup: Name: Katja Hashemi Elses, PhD studnet; Phone Number: +46705442505; Email: katja.hashemi-elses@mau.se

Study Locations

• Sweden
  • Skåne
    • Lund, Skåne, Sweden, 223 55
      • Not yet recruiting
      • Borgska Villans Specialisttandvård
    • Malmö, Skåne, Sweden, 214 21
      • Recruiting
      • Malmö universitet
      • Contact: Mikael Sonesson, Docent; Phone Number: +46406658447; Email: mikael.sonesson@mau.se
      • Contact: Katja Hashemi Elses, PHD student; Phone Number: +46464600130; Email: katja.hashemi-elses@mau.se
      • Principal Investigator: Katja Hashemi Elses, PhD studnet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The conventional surgical method; The conventional surgical method usually used in the clinic	Procedure: The novel surgical method; Additional bone removal in intended direction for tooth movement
Experimental: The novel surgical method; Additional bone removal in intendet direction of tooth movement	Procedure: The conventional surgical method; The conventional method to use surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment time for the canine to be exposed in the oral cavity	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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment time for the canine to align and reach its final position	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.	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported pain and discomfort	Patient-reported outcomes such as pain and discomfort during the treatment process will also be assessed using standardized questionnaires.	24 months

Collaborators and Investigators

• Sponsor: Malmö University
• Collaborators: Ortodontilund AB
• Investigators: Study Director: Mikael Sonesson, Docent, Malmö University

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2025
• Primary Completion (Estimated): January 10, 2026
• Study Completion (Estimated): July 10, 2026

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: impacted maxillary canines
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: Dnr 2023-02596-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No