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NCT Number: NCT03906422

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 will compare the discomfort levels engendered by the three wire types to determine if there is one that induces the least amount.

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Key information

Conditions

Orthodontic Discomfort Facial Pain Neurologic Manifestations Pain Pain, Orofacial Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado School of Dental Medicine

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Clifton Carey

CONTACT

[email protected]

303-724-1046

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3M Unitek 0.016 orthodontic archwire

Device

Placement of 3M Unitek 0.016 archwire for orthodontic treatment

Device: 0.016" Ormco 27oC NiTi orthodontic archwire

Device

Placement of 0.016" Ormco 27oC NiTi orthodontic archwire

Device: 0.016" Ormco 35oC NiTi orthodontic archwire

Device

Placement of 0.016" Ormco 35oC NiTi orthodontic archwire

Primary outcomes

  1. Pain score via Visual Analogue Score

    Time frame: 1 hour, 4 hour, 24 hour, 4 day and 7 day

    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 Score (VAS) where the higher the number the more intense the pain.

    The difference in VAS pain scores from the initial VAS after archwire insertion (1 hour) to each measurement time (4 hour, 24 hour, 4 day and 7 day) over 7 days will indicate the change pain experience for each study participant.

    For each time point the mean and standard deviation of the change in VAS pain scores for the experimental groups will be calculated and compared for statistically significant differences.

Study contacts

Contact information is provided by the study sponsor or research team.

Clifton M Carey, PhD

CONTACT

[email protected]

303-724-1046

Craig Shellhart, DDS

CONTACT

[email protected]

303-724-6993

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Acronym: Archwires

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Apr 8, 2019
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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