Impacted Canine and Mixed-reality Technology - RCT

August 25, 2024 updated by: Piotr Fudalej

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Kraków, Poland, 31-008
        • Recruiting
        • Jagiellonian University Medical College
        • Contact:
        • Sub-Investigator:
          • Agnieszka Garlicka, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HOLO+
Procedure: Planning of alignment with HoloLens 2
Planning of attachment position and traction direction with HoloLens 2 goggles
Active Comparator: HOLO-
Procedure: No planning of alignment with HoloLens 2
No planning of attachment position and traction direction with HoloLens 2 goggles

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Piotr Fudalej

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 25, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 25, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1072.6120.130.2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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