Impacted Canine and Mixed-reality Technology - RCT

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06574477

Enrollment

Registered

2024-08-28

Start date

2021-10-01

Completion date

2027-10-31

Last updated

2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth, Impacted

Brief summary

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

PROCEDUREPlanning of alignment with HoloLens 2

Planning of attachment position and traction direction with HoloLens 2 goggles

PROCEDURENo planning of alignment with HoloLens 2

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

10 Years to 20 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Alignment duration	6 months, 12 months	total duration of the phase of the alignment of impacted canine (in days)

Secondary

Measure	Time frame	Description
Resorption	6 months, 12 months	extent of root resorption of adjacent teeth measured on CBCT

Countries

Poland

Contacts

Primary ContactPiotr Fudalej, Prof.

piotr.fudalej@uj.edu.pl+48887970453

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026