Comparison of Patient-reported Pain After Initial Archwire Placement

Pain, Orofacial Clinical Trial

— Archwires  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03906422
• Other study ID #: 18-1737
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: June 1, 2025

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: Clifton M Carey, PhD
• Phone: 303-724-1046
• Email: clifton.carey[@]ucdenver.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Facial Pain
• Orthodontic Discomfort
• Pain, Orofacial

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	University of Colorado School of Dental Medicine	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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