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NCT05909254

Application of Surgical Templates in the Surgical Exposure of Impacted Canines

Active, enrolled NA Last updated 24 July 2024
What this trial tests

NA trial testing Palatally impacted canine exposure using a surgical guide in Impacted Tooth in 40 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 May 2023
Primary endpoint
30 April 2028
30 June 2028

Quick facts

Lead sponsorSemmelweis University
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment40
Start date1 May 2023
Primary completion30 April 2028
Estimated completion30 June 2028
Sites1 location across Hungary

Drugs / interventions tested

Conditions studied

Sponsor

Semmelweis University

Who can join

Adults 11 to 18, any sex, with Impacted Tooth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Computer-assisted open exposure of palatally impacted canines for orthodontic eruption: A randomized clinical trial.
    Kivovics M, Szanyi SM, Takács A, Répási M, et al · · 2024 · cited 6× · PMID 38906453 · DOI 10.1016/j.jdent.2024.105110

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