Impacted Canine and Mixed-reality Technology - RCT

ConditionTooth, Impacted

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age10-20

SponsorPiotr Fudalej

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Dental abnormalities (hyperodontia, hypodontia, etc.)

Impacted canines bilaterally

Previous trauma to the teeth or face

Congenital craniofacial malformations

Trial design

Design model

Parallel

Treatments tested in this trial

Planning of alignment with HoloLens 2
Procedure/Surgery
Planning of attachment position and traction direction with HoloLens 2 goggles
No planning of alignment with HoloLens 2
Procedure/Surgery
No planning of attachment position and traction direction with HoloLens 2 goggles

Treatment groups

72 Participants

are divided into 2 treatment groups

Group A: HOLO+Experimental treatment 1 intervention

Group B: HOLO-Active comparator 1 intervention

Trial outcomes

Primary outcomes

Alignment duration

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

Time frame

6 months, 12 months

Secondary outcomes

Resorption

extent of root resorption of adjacent teeth measured on CBCT

Time frame

6 months, 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Piotr Fudalej

Lead sponsor

Jagiellonian University

Sponsor institution

Source ClinicalTrials.gov

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