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RecruitingNCT06574477Updated Aug 28, 2024

Impacted Canine and Mixed-reality Technology - RCT

An interventional study of Planning of alignment with HoloLens 2 and No planning of alignment with HoloLens 2 in Tooth, Impacted, sponsored by Piotr Fudalej. Recruiting at 1 site in Poland. Open to participants aged 10 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-28.

Sponsored by Piotr Fudalej · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Oct 2021, registered Aug 2024).
  • Started Oct 2021; still recruiting 5 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
10 Years to 20 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tooth, Impacted

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03

In context

Tooth, Impacted

122 studies on the registry are indexed under Tooth, Impacted; 15 are open to participants now.

This study's planned enrollment of 72 is close to the median of 70 across 88 interventional studies indexed under Tooth, Impacted.

Browse Tooth, Impacted studies →

Lead sponsor

Piotr Fudalej is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    HOLO+

    Procedure: Planning of alignment with HoloLens 2

  • Active comparator
    HOLO-

    Procedure: No planning of alignment with HoloLens 2

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

06

What researchers measure

Primary outcomes

  1. Alignment duration

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

    Time frame: 6 months, 12 months

Secondary outcomes

  1. Resorption

    extent of root resorption of adjacent teeth measured on CBCT

    Time frame: 6 months, 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2021 (actual). Primary completion is estimated for Oct 2026, 60 months after the start.

Of 55 non-industry interventional studies with no phase under Tooth, Impacted, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's planned 60 months is above that.

Counting every sponsor, half of 56 studies reached it within 20 months; a quarter within 8 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2024
First posted
Aug 28, 2024
StartActual
Oct 1, 2021
Primary completionEst.
Oct 2026
CompletionEst.
Oct 2027
Last update
Aug 28, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06574477
Lead sponsor
Piotr Fudalej
Responsible party
Piotr Fudalej (Professor, Jagiellonian University) — Sponsor-investigator
First posted
Aug 28, 2024
Start date
Oct 1, 2021
Primary completion
Oct 2026 (estimated)
Completion
Oct 2027 (estimated)
Last update
Aug 28, 2024

Study contacts

Piotr Fudalej, Prof.
Contact
piotr.fudalej@uj.edu.pl
+48887970453

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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