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NCT03398798 · ClinicalTrials.gov registry record · NA
Analysis of Orthodontic Tooth Movement Using 3D Imaging
A NA study of Malocclusion and Dental Crowding, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT03398798: Completed NA study of Malocclusion and Dental Crowding, sponsored by University of North Carolina, Chapel Hill.
NCT03398798 is a NA study of Malocclusion and Dental Crowding that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 36 participants, below the 103-participant average among 6 other Malocclusion trials with a reported enrollment target (65% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03398798, a NA study of Malocclusion and Dental Crowding, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
Study Summary
Purpose: This project aims to study the effects of wire dimension and ligation method (bracket type) on the first stage of orthodontic treatment using 3D imaging. Participants: Up to 80 patients at UNC School of Dentistry or Selden Orthodontics between the ages of 10 and 45, inclusive, who have been previously diagnosed with malocclusion requiring orthodontic treatment (braces) and are otherwise healthy. Procedures (methods): Subjects receiving standard of care (SOC) orthodontic treatment will be randomized to one of two commonly used orthodontic archwires (.014" or .016" diameter). Subjects will be further subdivided for analysis based on the type of bracket (twin or self-ligating) that their clinician uses in their treatment. We will review the 3D digital images of each subject's dentition recorded as part of SOC at the 0-, 6- and 12-week visits. We will retrieve the archwires when they are removed per SOC by the clinician at the 12-week time point.
Primary Outcome
Little's Index measures the distance between contact points on adjacent teeth. Little's Index will be measured at two time points (0 weeks and 6 weeks).
Conditions Studied
Interventions
- DEVICE .014"
- DEVICE .016"
- DEVICE Twin brackets
- DEVICE Self-ligating brackets
Study Locations (2)
North Carolina
- UNC-CH School of Dentistry - Chapel Hill
- Selden Orthodontics - Huntersville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-01-15 |
| Est. Completion | 2018-11-29 |
| Phase | NA |
What the finished NCT03398798 record still lists
NCT03398798 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 103-participant average among 6 other Malocclusion trials with a reported enrollment target (65% lower).
The record links to 3 conditions, with Malocclusion appearing as the primary indexed condition, and to 4 interventions - of which .014" is the first listed.
NCT03398798 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03398798 about?
NCT03398798 is a clinical study titled "Analysis of Orthodontic Tooth Movement Using 3D Imaging". Purpose: This project aims to study the effects of wire dimension and ligation method (bracket type) on the first stage of orthodontic treatment using 3D imaging. Participants: Up to 80 patients at UNC School of Dentistry or Selden Orthodontics between the ages of 10 and 45, inclusive, who have bee...
What is the current status of trial NCT03398798?
This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2018-01-15. Estimated completion is 2018-11-29.
What conditions does trial NCT03398798 study?
This clinical trial studies the following conditions: Malocclusion, Dental Crowding, Tooth Crowding.
What interventions are being tested in trial NCT03398798?
The interventions under investigation include: .014" (DEVICE), .016" (DEVICE), Twin brackets (DEVICE), Self-ligating brackets (DEVICE).
Who is sponsoring clinical trial NCT03398798?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03398798 being conducted?
This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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