RecruitingNot ApplicableNCT03906422

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


Sponsor

University of Colorado, Denver

Enrollment

126 participants

Start Date

May 10, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Inclusion Criteria5

  • 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

Exclusion Criteria6

  • 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

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Interventions

DEVICE3M Unitek 0.016 orthodontic archwire

Placement of 3M Unitek 0.016 archwire for orthodontic treatment

DEVICEDevice: 0.016" Ormco 27oC NiTi orthodontic archwire

Placement of 0.016" Ormco 27oC NiTi orthodontic archwire

DEVICEDevice: 0.016" Ormco 35oC NiTi orthodontic archwire

Placement of 0.016" Ormco 35oC NiTi orthodontic archwire


Locations(1)

University of Colorado School of Dental Medicine

Aurora, Colorado, United States

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NCT03906422


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