Comparison of Patient-reported Pain After Initial Archwire Placement

NCT ID: NCT03906422

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-10
• Study Completion Date: 2028-06-01

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.

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.

Conditions

Orthodontic Discomfort; Pain, Orofacial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

3M Unitek 0.016 orthodontic archwire

Intervention Type: DEVICE

Placement of 3M Unitek 0.016 archwire for orthodontic treatment

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.

Group Type: EXPERIMENTAL

Device: 0.016" Ormco 27oC NiTi orthodontic archwire

Intervention Type: DEVICE

Placement of 0.016" Ormco 27oC NiTi orthodontic archwire

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.

Group Type: EXPERIMENTAL

Device: 0.016" Ormco 35oC NiTi orthodontic archwire

Intervention Type: DEVICE

Placement of 0.016" Ormco 35oC NiTi orthodontic archwire

Interventions

3M Unitek 0.016 orthodontic archwire

Placement of 3M Unitek 0.016 archwire for orthodontic treatment

Intervention Type: DEVICE

Device: 0.016" Ormco 27oC NiTi orthodontic archwire

Placement of 0.016" Ormco 27oC NiTi orthodontic archwire

Intervention Type: DEVICE

Device: 0.016" Ormco 35oC NiTi orthodontic archwire

Placement of 0.016" Ormco 35oC NiTi orthodontic archwire

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Colorado School of Dental Medicine

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clifton M Carey, PhD

Role: CONTACT

clifton.carey@ucdenver.edu

303-724-1046

Craig Shellhart, DDS

Role: CONTACT

craig.shellhart@ucdenver.edu

303-724-6993

Facility Contacts

Clifton Carey

Role: primary

clifton.carey@cuanschutz.edu

303-724-1046

References

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.

Reference Type: BACKGROUND

PMID: 22259810 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21856007 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 17488999 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16000093 (View on PubMed)

Other Identifiers

18-1737

Identifier Type: -

Identifier Source: org_study_id