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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Orthodontic Discomfort; Pain, Orofacial
• Intervention / Treatment: Device: 3M Unitek 0.016 orthodontic archwire; Device: Device: 0.016" Ormco 27oC NiTi orthodontic archwire; Device: Device: 0.016" Ormco 35oC NiTi orthodontic archwire

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clifton M Carey, PhD; Phone Number: 303-724-1046; Email: clifton.carey@ucdenver.edu
• Study Contact Backup: Name: Craig Shellhart, DDS; Phone Number: 303-724-6993; Email: craig.shellhart@ucdenver.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado School of Dental Medicine
      • Contact: Clifton Carey; Phone Number: 303-724-1046; Email: clifton.carey@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 3M Unitek 0.016 orthodontic archwire; Placement of 3M Unitek 0.016 archwire for orthodontic treatment
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.	Device: Device: 0.016" Ormco 27oC NiTi orthodontic archwire; Placement of 0.016" Ormco 27oC NiTi orthodontic archwire
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.	Device: Device: 0.016" Ormco 35oC NiTi orthodontic archwire; Placement of 0.016" Ormco 35oC NiTi orthodontic archwire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Orthodontic
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Facial Pain
• Other Study ID Numbers: 18-1737

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The COMIRB approval and the consent forms specify that we cannot share PHI except as mandated by law. Therefore we do not intend to share any IPD to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes