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NCT Number: NCT06574477

Impacted Canine and Mixed-reality Technology - RCT

The goal of this clinical trial is to determine whether the use of HoloLens 2 mixed reality goggles for planning alignment of palatally impacted canine reduces: 1) treatment time and 2) the risk of complications compared to planning alignment of palatally impacted canine without HoloLens 2 goggles.

Participants will have an impacted canine on palatal side.

Researchers will use or will not use HoloLens 2 goggles in planning therapy

Participants will wear fixed orthodontic appliances for the treatment of impacted canine. During treatment, attachment will fixed to an impacted canine and the direction of traction will be established.

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Key information

Conditions

Tooth, Impacted Stomatognathic Diseases Tooth Diseases

Age range

10 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jagiellonian University Medical College

Krakow, 31-008, Poland

Location status: Recruiting

Location contact

Agnieszka Garlicka, DDS

SUB_INVESTIGATOR

Piotr Fudalej

CONTACT

[email protected]

+48887970453

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy boys/men and girls/women aged between 10 and 20 years.
  • Palatally impacted canine on one side
  • Axis of the canine > 10 degrees to the midline as measured on a pantomographic radiograph
  • During orthodontic treatment, in preparation for alignment of the impacted canine with adequate space for the retained canine

Exclusion criteria

  • Dental abnormalities (hyperodontia, hypodontia, etc.)
  • Impacted canines bilaterally
  • Previous trauma to the teeth or face
  • Congenital craniofacial malformations
  • Systemic diseases that would hinder orthodontic treatment/operation
  • Recent radiotherapy

Treatment and study plan

Planning of alignment with HoloLens 2

Procedure

Planning of attachment position and traction direction with HoloLens 2 goggles

No planning of alignment with HoloLens 2

Procedure

No planning of attachment position and traction direction with HoloLens 2 goggles

Primary outcomes

  1. Alignment duration

    Time frame: 6 months, 12 months

    total duration of the phase of the alignment of impacted canine (in days)

Secondary outcomes

  1. Resorption

    Time frame: 6 months, 12 months

    extent of root resorption of adjacent teeth measured on CBCT

Study contacts

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

Piotr Fudalej, Prof.

CONTACT

[email protected]

+48887970453

Sponsors and collaborators

Lead sponsor

Piotr Fudalej

Other

Registry information

Official study title

Alignment of an Impacted Canine Using Mixed-reality HoloLens 2 Goggles - a Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

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.

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