Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT03906422

Conditions

Orthodontic Discomfort

Pain, Orofacial

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Interventions

3M Unitek 0.016 orthodontic archwire

Device: 0.016" Ormco 27oC NiTi orthodontic archwire

Device: 0.016" Ormco 35oC NiTi orthodontic archwire

Study Details

Brief 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.

Conditions

Orthodontic Discomfort

Pain, Orofacial

Study ID

NCT03906422

Start date

May 10, 2019

Status verified date

May, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: A: 0.016" Nitinol

0.016" Nitinol (3M Unitek, Monrovia, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment.

experimental: B: 0.016" Ormco 27oC NiTi

0.016" Ormco 27oC NiTi (Ormco, Glendora, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment.

experimental: C: 0.016" Ormco 35oC NiTi

0.016" Ormco 35oC NiTi (Ormco, Glendora, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment.

Interventions

3M Unitek 0.016 orthodontic archwire

Placement of 3M Unitek 0.016 archwire for orthodontic treatment

Device: 0.016" Ormco 27oC NiTi orthodontic archwire

Placement of 0.016" Ormco 27oC NiTi orthodontic archwire

Device: 0.016" Ormco 35oC NiTi orthodontic archwire

Placement of 0.016" Ormco 35oC NiTi orthodontic archwire

Primary outcome measure

  • Pain score via Visual Analogue Score [ Time Frame: 1 hour, 4 hour, 24 hour, 4 day and 7 day ]

Central Contacts and Locations

Central contacts

Clifton M Carey, PhD

303-724-1046clifton.carey@ucdenver.edu

Craig Shellhart, DDS

303-724-6993craig.shellhart@ucdenver.edu

Locations

University of Colorado School of Dental Medicine

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Clifton Carey

303-724-1046clifton.carey@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • Orthodontic
  • Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-05-14.