Comparison of Patient-reported Pain After Initial Archwire Placement

NCT03906422 | Recruiting FDA Device

• 1 other identifier: 18-1737
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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

Keywords

Orthodontic; Pain

Outcome Measures

Primary Outcomes (1)

• Pain score via Visual Analogue Score

  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.

  1 hour, 4 hour, 24 hour, 4 day and 7 day

Study Arms (3)

A: 0.016" Nitinol

EXPERIMENTAL

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

Device: 3M Unitek 0.016 orthodontic archwire

B: 0.016" Ormco 27oC NiTi

EXPERIMENTAL

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

Device: Device: 0.016" Ormco 27oC NiTi orthodontic archwire

C: 0.016" Ormco 35oC NiTi

EXPERIMENTAL

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

Device: Device: 0.016" Ormco 35oC NiTi orthodontic archwire

Interventions

3M Unitek 0.016 orthodontic archwire DEVICE

Placement of 3M Unitek 0.016 archwire for orthodontic treatment

A: 0.016" Nitinol

Device: 0.016" Ormco 27oC NiTi orthodontic archwire DEVICE

Placement of 0.016" Ormco 27oC NiTi orthodontic archwire

B: 0.016" Ormco 27oC NiTi

Device: 0.016" Ormco 35oC NiTi orthodontic archwire DEVICE

Placement of 0.016" Ormco 35oC NiTi orthodontic archwire

C: 0.016" Ormco 35oC NiTi

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado School of Dental Medicine

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (4)

• Cioffi I, Piccolo A, Tagliaferri R, Paduano S, Galeotti A, Martina R. Pain perception following first orthodontic archwire placement--thermoelastic vs superelastic alloys: a randomized controlled trial. Quintessence Int. 2012 Jan;43(1):61-9.

  PMID: 22259810 BACKGROUND

• Graf M, Alhammouri Q, Vieregge C, Lorenz B. The Bruckner transillumination test: limited detection of small-angle esotropia. Ophthalmology. 2011 Dec;118(12):2504-9. doi: 10.1016/j.ophtha.2011.05.016.

  PMID: 21856007 BACKGROUND

• Krishnan V. Orthodontic pain: from causes to management--a review. Eur J Orthod. 2007 Apr;29(2):170-9. doi: 10.1093/ejo/cjl081.

  PMID: 17488999 BACKGROUND

• Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.

  PMID: 16000093 BACKGROUND

MeSH Terms

Conditions

Facial Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clifton M Carey, PhD

CONTACT

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

Craig Shellhart, DDS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator will assemble the opaque, sealed envelopes containing the archwires. The envelopes will be labeled "A", "B" or "C" corresponding to 0.016" Nitinol (3M Unitek, Monrovia, CA), 0.016" 27o CuNiTi (Ormco, Glendora, CA) or 0.016" 35o CuNiTi (Ormco, Glendora, CA) respectively. Randomization sequences will be created by using Research Randomizer online software. The investigator will enroll patients into the study. This trial will be completed with two blocks of 63 subjects each, one block per year, with subject randomization within each block. An independent third party will maintain possession of all envelopes and distribute as needed once a subject is enrolled and ready to receive fixed orthodontic appliances. The same independent third party will maintain a log with subject identification and consent forms.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, triple-blind, randomized controlled clinical trial

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: April 8, 2019
• Study Start: May 10, 2019
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)