Impacted Canine and Mixed-reality Technology - RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Planning of alignment with HoloLens 2, No planning of alignment with HoloLens 2.
- Who it may be relevant to
- Registry conditions: Tooth, Impacted. Basic parameters: 10 years — 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Alignment of an Impacted Canine Using Mixed-reality HoloLens 2 Goggles - a Randomized Clinical Trial
Overview
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.
Interventions
- Procedure Planning of alignment with HoloLens 2
Planning of attachment position and traction direction with HoloLens 2 goggles - Procedure No planning of alignment with HoloLens 2
No planning of attachment position and traction direction with HoloLens 2 goggles
Primary outcome measures
- Alignment duration [Time frame: 6 months, 12 months]
Secondary outcome measures (1)
- Resorption [Time frame: 6 months, 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- Jagiellonian University Medical College — Krakow
Identifiers
NCT: NCT06574477 · 1072.6120.130.2021