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

NCT06833034 | Recruiting DMC

• 1 other identifier: Dnr 2023-02596-02
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

impacted maxillary canines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  24 months

Other Outcomes (1)

• Patient-reported pain and discomfort

  24 months

Study Arms (2)

The conventional surgical method

ACTIVE COMPARATOR

The conventional surgical method usually used in the clinic

Procedure: The novel surgical method

The novel surgical method

EXPERIMENTAL

Additional bone removal in intendet direction of tooth movement

Procedure: The conventional surgical method

Interventions

The novel surgical method PROCEDURE

Additional bone removal in intended direction for tooth movement

The conventional surgical method

The conventional surgical method PROCEDURE

The conventional method to use surgery

The novel surgical method

Eligibility Criteria

• Age: 10 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with palatally impacted maxillary canine on one side, in sector 2-4 and with angle \<45º are included.

You may not qualify if:

• 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

Sponsors & Collaborators

• Malmö University: lead
• Ortodontilund AB: collaborator

Study Sites (2)

Borgska villans specialisttandvård

Lund, Skåne County, 223 55, Sweden

NOT YET RECRUITING

Malmö universitet

Malmo, Skåne County, 214 21, Sweden

RECRUITING

Study Officials

• Mikael Sonesson, Docent

  Malmö University

  STUDY DIRECTOR

Central Study Contacts

Mikael Sonesson, Docent

CONTACT

SWE: 040 665 84 47; mikael.sonesson@mau.se

Katja Hashemi Elses, PhD studnet

CONTACT

+46705442505; katja.hashemi-elses@mau.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Surgical technique After anesthesia and rising of the mucoperiosteal flap the patients are randomized, by a staff member not involved in the study, for further treatment into one of two groups: A) The conventional surgical procedure without additional bone removal and B) the novel surgical procedure with additional bone removal. In the end of the surgical session, the auxiliary attachment is placed on the crown of the canine and the incision is made on the palatal flap letting the chain protrude exactly where the canine is placed. The flap is then sutured with conventional sutures and the patients are instructed to rinse with Chlorhexidine until the sutures are removed after 10 days at the orthodontic clinic and the chain is activated and followed as normal procedure in the orthodontic treatment. The surgery will be performed by one surgeon. The orthodontic treatment will be performed by four orthodontists at the three orthodontic clinics.

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: March 7, 2025
• Primary Completion: January 10, 2026
• Study Completion (Estimated): July 10, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)