Comparison of Patient-reported Pain After Initial Archwire Placement (Archwires)

  • End date
    Jun 1, 2024
  • participants needed
  • sponsor
    University of Colorado, Denver
Updated on 11 February 2022
tooth extraction
Accepts healthy volunteers


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.


Orthodontic treatment with fixed appliances has the potential to induce pain in patients. At the beginning of treatment, the orthodontist must determine which initial orthodontic archwire to insert. Among the more popular choices for initial leveling and aligning of the dental arches are small-sized, round-diameter nickel-titanium archwires. Various types of nickel-titanium (NiTi) archwires exist including stabilized martensitic wires (ie classic Nitinol), active austenitic wires (superelastic NiTi) and active martensitic wires (thermoelastic NiTi). The efficacy of these wire types has been heavily researched with no significant differences in the alignment timing of the dentition (treatment time to reach the final archwire). Pain differences from these wires has been inconclusive from conflicting past studies. It is of critical importance to determine whether one or more of these archwires leads to more discomfort for the patient than the others.

Condition Orthodontic Discomfort, Pain, Orofacial
Treatment 3M Unitek 0.016 orthodontic archwire, Device: 0.016" Ormco 27oC NiTi orthodontic archwire, Device: 0.016" Ormco 35oC NiTi orthodontic archwire
Clinical Study IdentifierNCT03906422
SponsorUniversity of Colorado, Denver
Last Modified on11 February 2022


Yes No Not Sure

Inclusion Criteria

Healthy, with no significant systemic diseases or complications or special needs
Requiring a minimum of 1 dental arch (first molar to first molar) labial fixed orthodontic appliance banded/bonded in 1 appointment
All banded/bonded teeth can be ligated to initial archwire (no severely displaced or blocked out teeth)
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
Age 12 years or older

Exclusion Criteria

Currently taking or recently taken sulfonamides, monoamine oxidase inhibitors, tricyclic antidepressants, or phenothiazines
Currently taking physician-prescribed medical marijuana for the management of pain or recreational marijuana during the trial period
Metal-type (Nickel) allergies
Less than 12 years old
Same day use of analgesics prior to bonding
Treatment requiring dental extractions prior to or immediately after bonding of fixed appliance
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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