Tooth, ImpactedNCT06574477
Impacted Canine and Mixed-reality Technology - RCT
A study testing Planning of alignment with HoloLens 2 and No planning of alignment with HoloLens 2 in people with Tooth, Impacted, run by Piotr Fudalej at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth, Impacted
- What is being tested?
- Planning of alignment with HoloLens 2 and No planning of alignment with HoloLens 2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2021to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Jagiellonian University Medical College
Krakow, 31-008
Piotr Fudalej, +48887970453, piotr.fudalej@uj.edu.pl
Agnieszka Garlicka, DDS
About this study
Official title: 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.
- Conditions
- Tooth, Impacted
- Being tested
- Planning of alignment with HoloLens 2, No planning of alignment with HoloLens 2
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planning of alignment with HoloLens 2Procedure or surgery
Planning of attachment position and traction direction with HoloLens 2 goggles
No planning of alignment with HoloLens 2Procedure or surgery
No planning of attachment position and traction direction with HoloLens 2 goggles
| Study group | Role | What they receive |
|---|---|---|
| HOLO+ | Experimental | Not described Receives: Procedure: Planning of alignment with HoloLens 2 |
| HOLO- | Active comparator | Not described Receives: Procedure: No planning of alignment with HoloLens 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alignment duration
total duration of the phase of the alignment of impacted canine (in days)
Measured: 6 months, 12 months
Secondary outcomes (1)
Resorption
extent of root resorption of adjacent teeth measured on CBCT
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Oct 2021
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth, ImpactedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Piotr Fudalej
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Piotr Fudalej, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574477
- Sponsor's protocol ID
- 1072.6120.130.2021
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alignment of an Impacted Canine Using Mixed-reality HoloLens 2 Goggles - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06574477
- Acronym / sponsor ID
- 1072.6120.130.2021
- Conditions
- Tooth, Impacted
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Piotr FudalejUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOLO+ | Experimental | Procedure: Planning of alignment with HoloLens 2 |
| HOLO- | Active comparator | Procedure: No planning of alignment with HoloLens 2 |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Planning of alignment with HoloLens 2Planning of attachment position and traction direction with HoloLens 2 goggles | Procedure or surgery | HOLO+ |
| No planning of alignment with HoloLens 2No planning of attachment position and traction direction with HoloLens 2 goggles | Procedure or surgery | HOLO- |
Primary outcome
Alignment duration
Time frame: 6 months, 12 months
total duration of the phase of the alignment of impacted canine (in days)
1 secondary outcome
Resorption
Time frame: 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Planning of alignment with HoloLens 2 and No planning of alignment with HoloLens 2 in people with Tooth, Impacted, run by Piotr Fudalej at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piotr Fudalej, Prof. (+48887970453, piotr.fudalej@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alignment duration (time frame: 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.