← Back to Search

Archwire Types for Orthodontic Discomfort (Archwires Trial)

N/A
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 12 years or older
Requiring a minimum of 1 dental arch (first molar to first molar) labial fixed orthodontic appliance banded/bonded in 1 appointment
Must not have
Less than 12 years old
Currently taking or recently taken sulfonamides, monoamine oxidase inhibitors, tricyclic antidepressants, or phenothiazines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour, 4 hour, 24 hour, 4 day and 7 day
Awards & highlights
No Placebo-Only Group

Summary

This trial will test which of three types of 'archwires' used in Orthodontic treatment causes the least patient discomfort.

Who is the study for?
This trial is for healthy individuals aged 12 or older who need orthodontic treatment with fixed appliances across at least one dental arch. Participants should not have metal allergies, be on certain medications like antidepressants, or use marijuana. Any necessary dental extractions must occur 3 weeks before or after the appliance is fitted.
What is being tested?
The study tests three types of orthodontic 'archwires' to see which causes the least discomfort during treatment. The type of wire used will be chosen by the treating Orthodontist without any bias towards effectiveness as all are considered equally effective.
What are the potential side effects?
Potential side effects may include varying levels of facial and oral pain associated with each type of archwire used in the orthodontic treatment, but no specific side effects are attributed to the wires themselves.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 12 years old or older.
Select...
I need braces on at least one arch of my teeth in one visit.
Select...
All my teeth can be attached to the initial braces wire.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under 12 years old.
Select...
I am currently taking or have recently taken certain medications like sulfonamides or antidepressants.
Select...
I need teeth removed before or right after getting braces.
Select...
I am using medical marijuana prescribed by a doctor or recreational marijuana.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour, 4 hour, 24 hour, 4 day and 7 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour, 4 hour, 24 hour, 4 day and 7 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: C: 0.016" Ormco 35oC NiTiExperimental Treatment1 Intervention
0.016" Ormco 35oC NiTi (Ormco, Glendora, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment.
Group II: B: 0.016" Ormco 27oC NiTiExperimental Treatment1 Intervention
0.016" Ormco 27oC NiTi (Ormco, Glendora, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment.
Group III: A: 0.016" NitinolExperimental Treatment1 Intervention
0.016" Nitinol (3M Unitek, Monrovia, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,919,854 Total Patients Enrolled

Media Library

0.016" Ormco 27oC NiTi orthodontic archwire Clinical Trial Eligibility Overview. Trial Name: NCT03906422 — N/A
Orthodontic Discomfort Research Study Groups: A: 0.016" Nitinol, B: 0.016" Ormco 27oC NiTi, C: 0.016" Ormco 35oC NiTi
Orthodontic Discomfort Clinical Trial 2023: 0.016" Ormco 27oC NiTi orthodontic archwire Highlights & Side Effects. Trial Name: NCT03906422 — N/A
0.016" Ormco 27oC NiTi orthodontic archwire 2023 Treatment Timeline for Medical Study. Trial Name: NCT03906422 — N/A
~9 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top