Impacted Canine and Mixed-reality Technology - RCT

Piotr Fudalej

Status: Enrolling

Conditions: Tooth, Impacted

Treatments: Procedure: Planning of alignment with HoloLens 2; Procedure: No planning of alignment with HoloLens 2

Study type: Interventional

Funder types: Other

Identifiers

NCT06574477

1072.6120.130.2021

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 10 to 20 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

72 participants in 2 patient groups

HOLO+

Experimental group

Treatment:

Procedure: Planning of alignment with HoloLens 2

HOLO-

Active Comparator group

Treatment:

Procedure: No planning of alignment with HoloLens 2