NCT03906422

Comparison of Patient-reported Pain After Initial Archwire Placement

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	3M Unitek 0.016 orthodontic archwire	Placement of 3M Unitek 0.016 archwire for orthodontic treatment
DEVICE	Device: 0.016" Ormco 27oC NiTi orthodontic archwire	Placement of 0.016" Ormco 27oC NiTi orthodontic archwire
DEVICE	Device: 0.016" Ormco 35oC NiTi orthodontic archwire	Placement of 0.016" Ormco 35oC NiTi orthodontic archwire

Timeline

• Start date: 2019-05-10
• Primary completion: 2027-06-01
• Completion: 2028-06-01
• First posted: 2019-04-08
• Last updated: 2025-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study