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Comparison of Patient-reported Pain After Initial Archwire Placement

Comparison of Patient-reported Pain After Initial Archwire Placement With Three Types of Nickel-titanium Archwires: a Prospective Triple-blind, Randomized Controlled Clinical Trial

Who can join

Ages 12 and older · All sexes · Healthy volunteers welcome

Inclusion Criteria:

1. Healthy, with no significant systemic diseases or complications or special needs
2. Requiring a minimum of 1 dental arch (first molar to first molar) labial fixed orthodontic appliance banded/bonded in 1 appointment
3. All banded/bonded teeth can be ligated to initial archwire (no severely displaced or blocked out teeth).
4. Any planned dental extractions that is part of the orthodontic treatment plan must be carried out at least 3 weeks prior to or after initial orthodontic appliance bonding.
5. Age 12 years or older

Exclusion Criteria:

1. Currently taking or recently taken sulfonamides, monoamine oxidase inhibitors, tricyclic antidepressants, or phenothiazines
2. Currently taking physician-prescribed medical marijuana for the management of pain or recreational marijuana during the trial period
3. Metal-type (Nickel) allergies
4. Less than 12 years old
5. Same day use of analgesics prior to bonding
6. Treatment requiring dental extractions prior to or immediately after bonding of fixed appliance

About the study

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.

What is being tested

• 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)

Sponsor: University of Colorado, Denver · Participants: 126 · Started: May 10, 2019

Contact the study team

• Clifton M Carey, PhD · Phone: 303-724-1046
• Craig Shellhart, DDS · Phone: 303-724-6993

Official record on ClinicalTrials.gov — NCT03906422

Locations in the U.S.

Conditions

• Facial Pain
• Pain

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.