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Application of Surgical Templates in the Surgical Exposure of Impacted Canines

NCT05909254 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-22

No results posted yet for this study

Summary

The first choice therapy in case of palatally impacted canines is their exposure and orthodontic eruption to improve facial esthetics and prevent pathologies associated with impacted teeth and Temporomandibular Joint Disorders. Current solutions in digital dentistry allow the registration of three dimensional imaging datasets such as cone beam computed tomography (CBCT) and digital impression of the dentition and soft tissues obtained via intraoral scanning using orthodontic planning software. This allows the surgeon to visualize the position of the impacted canine prior to surgery and to design and manufacture a surgical guide to aid in the localization of the impacted tooth during surgery.

The aim of this randomized clinical trial is to assess the feasibility of surgical exposure of palatally impacted upper canines with open-eruption technique using a surgical template. The secondary purpose of this study is to compare this method with the conventional free-hand surgical exposure.

Patients included in this study are randomly assigned to two study groups. In Group 1 surgical exposure for open eruption of palatally impacted canines is performed following virtual planning using a surgical template. In Group 2 surgical exposure for open-eruption of palatally impacted canines is carried out using the conventional free-hand method.

We hypothesize that guided exposure of the impacted canines will be as successful as the conventional method with shorter surgical intervention and higher associated costs.

Conditions

  • Impacted Tooth

Interventions

OTHER

Palatally impacted canine exposure using a surgical guide

Under local anaesthesia the tissues covering the palatally impacted canine are removed with the help of a surgical guide to expose the tooth, to allow the bonding of an attachment on its surface for orthodontic traction.

OTHER

Palatally impacted canine exposure using the conventional free.hand method

Under local anaesthesia the tissues covering the palatally impacted canine are removed to expose the tooth, to allow the bonding of an attachment on its surface for orthodontic traction. The surgeon relies on the surgical plan and their experience to localize the impacted canine.

Sponsors & Collaborators

  • Semmelweis University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2028-04-30
Completion
2028-06-30

Countries

  • Hungary

Study Locations

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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 NCT05909254 on ClinicalTrials.gov