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NCT03906422 · ClinicalTrials.gov registry record · NA
Comparison of Patient-reported Pain After Initial Archwire Placement
A NA study of Pain, Orofacial and Orthodontic Discomfort, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- NA
- Development phase
- 126
- Enrollment target
- 1
- Study location
NCT03906422: Recruiting NA study of Pain, Orofacial and Orthodontic Discomfort, sponsored by University of Colorado, Denver.
NCT03906422 is a NA study of Pain, Orofacial and Orthodontic Discomfort that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 126 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03906422, a NA study of Pain, Orofacial and Orthodontic Discomfort, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- NA
- Development phase
- 126 participants
- Enrollment target
- 1
- Study location
Study Summary
Three different types of 'archwires' can be used in Orthodontic treatment, wire choice is decided by treating Orthodontist based on professional preference since research shows that all types are equally effective. It is possible that one type of wire engenders more patient discomfort. This study will compare the discomfort levels engendered by the three wire types to determine if there is one that induces the least amount.
Primary Outcome
The primary outcome is the change in pain experienced by the study participant over the first week of therapy after insertion of the archwire. Pain is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of pain being experienced. The left end of the line is no pain where the right end is maximum (unimaginable) pain. The specific pain indicated is in the number of millimeters from the left end of the line. This is called the Visual Analogue
Conditions Studied
Interventions
- DEVICE 3M Unitek 0.016 orthodontic archwire
- DEVICE Device: 0.016" Ormco 27oC NiTi orthodontic archwire
- DEVICE Device: 0.016" Ormco 35oC NiTi orthodontic archwire
Study Locations (1)
Colorado
- University of Colorado School of Dental Medicine - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2019-05-10 |
| Est. Completion | 2028-06-01 |
| Phase | NA |
What NCT03906422 shows while recruiting
NCT03906422 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Pain, Orofacial appearing as the primary indexed condition, and to 3 interventions - of which 3M Unitek 0.016 orthodontic archwire is the first listed.
NCT03906422 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT03906422 about?
NCT03906422 is a clinical study titled "Comparison of Patient-reported Pain After Initial Archwire Placement". Three different types of 'archwires' can be used in Orthodontic treatment, wire choice is decided by treating Orthodontist based on professional preference since research shows that all types are equally effective. It is possible that one type of wire engenders more patient discomfort. This study w...
What is the current status of trial NCT03906422?
This trial is currently recruiting. It is a NA study. The enrollment target is 126 participants. The study started on 2019-05-10. Estimated completion is 2028-06-01.
What conditions does trial NCT03906422 study?
This clinical trial studies the following conditions: Pain, Orofacial, Orthodontic Discomfort.
What interventions are being tested in trial NCT03906422?
The interventions under investigation include: 3M Unitek 0.016 orthodontic archwire (DEVICE), Device: 0.016" Ormco 27oC NiTi orthodontic archwire (DEVICE), Device: 0.016" Ormco 35oC NiTi orthodontic archwire (DEVICE).
Who is sponsoring clinical trial NCT03906422?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03906422 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03906422's enrollment target sits among peer trials
126 749th of 2000 higher than 1,248 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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