Impacted Canine and Mixed-reality Technology - RCT | NCT06574477

Studies
Impacted Canine and Mixed-reality Technology - RCT

NCT06574477

Sponsor

Piotr Fudalej

Status

Recruiting

Last Update Posted

Aug 28, 2024Actual

Enrollment

72Estimated

Phase

Not Applicable

Conditions

Tooth, Impacted

Interventions

Planning of alignment with HoloLens 2
No planning of alignment with HoloLens 2

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

Oct 2026Estimated

Completion Date

Oct 2027Estimated

First Submitted Date

Aug 13, 2024

First Submission Date that Met QC Criteria

Aug 25, 2024

First Posted Date

Aug 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2024

Last Update Posted Date

Aug 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HOLO+	Experimental		Procedure: Planning of alignment with HoloLens 2
HOLO-	Active Comparator		Procedure: No planning of alignment with HoloLens 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Planning of alignment with HoloLens 2	Procedure	Planning of attachment position and traction direction with HoloLens 2 goggles	HOLO+

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Piotr Fudalej, Prof.	Contact	+48887970453		piotr.fudalej@uj.edu.pl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jagiellonian University Medical College	Recruiting	Krakow		31-008	Poland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014095	Tooth, Impacted

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided