- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05780788
Characterizing Orthodontic Tooth Movement With Photographic Scans
November 27, 2023 updated by: Flavio Uribe, UConn Health
Characterizing Orthodontic Tooth Movement in Real Time Using Dental Monitoring Scans: a Pilot Study
Characterizing orthodontic tooth movements in real time by using photographic scans to monitor teeth movement.
The photographic scans will also be compared to 3D model scans.
Canine retraction over the course of 1 orthodontic visit will be measured.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The accuracy and reliability of Dental Monitoring scans is be evaluated and compared to that of iTero digital scans during maxillary canine retraction.
The magnitude and type of tooth movement occurring in a one month period in patients undergoing maxillary canine retraction will be measured.
Patients undergoing orthodontic treatment in the Center for Orthodontic Care at UConn Health will be evaluated for the inclusion criteria.
A total of twenty patients whose orthodontic treatment plan required extraction of at least one premolar in the maxillary arch will be recruited.
The patient will be required to take photographs and video scans as dictated by Dental Monitoring (DM) on the first and final days of the study period (four weeks), while iTero scans are taken by the provider in clinic on these same days.
Patient will also be periodically taking photographic scans at home using Dental Monitoring.
The DM scans taken by the patient will be compared to the iTero digital scans taken by the provider.
This can be done by superimposing the stereolithographic (STL) files created from each scan and assessing the amount of deviation between the 3D models.
The types of tooth movement occurring during canine retraction in buccolingual, mesiodistal, and incisogingival planes will be quantified using Doctor Dashboard software available in DM.
DM's 3D matching technology allows superimposition of teeth from each 3D model created per scan.
Each tooth and its movements are graphed in a detailed manner to provide precise information about its type of movement.
Study Type
Interventional
Enrollment (Estimated)
30
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
- Name: Flavio Uribe, DDS
- Phone Number: 8606793656
- Email: furibe@uchc.edu
Study Contact Backup
- Name: Michael Nedjat-Haiem, DDS
- Phone Number: 3106669024
- Email: nedjathaiem@uchc.edu
Study Locations
-
-
Connecticut
-
Farmington, Connecticut, United States, 06030
- Recruiting
- UConn Health
-
Contact:
- Michael Nedjat-Haiem, DDS
- Phone Number: 3106669024
- Email: nedjathaiem@uchc.edu
-
Contact:
- Flavio Uribe, DDS
- Phone Number: 860-679-3170
- Email: furibe@uchc.edu
-
Principal Investigator:
- Flavio Uribe, 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
11 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients with fixed orthodontic appliances
- Treatment plan requiring extraction of at least one maxillary premolar
- Male and female
- Permanent dentition from first molar to first molar in the maxilla
- Teeth with normal crown morphology
- Fully erupted canines
- Above 11 years of age
- Patients with any cellular phone with a camera
Exclusion Criteria:
- Lack of extraction in orthodontic treatment plan
- Syndromic patients
- Cleft lip/palate patients
- Removable appliances
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Canine retraction arm
Canine retraction
|
Monitoring Canine Retraction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy between patient-taken DM scan and provider-taken iTero scan
Time Frame: 1 month
|
Deviation between the photographic and intraoral scan.
Will be measured in mm in three planes of space.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tracking tooth movement
Time Frame: 1 month
|
Magnitude of canine tooth movement for every 4-5 days during a one month period.
Measurements will be done in mm and degrees in three planes of space.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Flavio Uribe, DDS, UConn Health
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)
December 31, 2020
Primary Completion (Estimated)
July 30, 2024
Study Completion (Estimated)
July 30, 2024
Study Registration Dates
First Submitted
February 28, 2023
First Submitted That Met QC Criteria
March 9, 2023
First Posted (Actual)
March 23, 2023
Study Record Updates
Last Update Posted (Actual)
November 28, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 21-113-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
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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