Comparison of Patient-reported Pain After Initial Archwire Placement

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03906422
Status
Recruiting
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Conditions

  • Orthodontic Discomfort
  • Pain, Orofacial

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 3M Unitek 0.016 orthodontic archwire — DEVICE
    Placement of 3M Unitek 0.016 archwire for orthodontic treatment
  • Device: 0.016" Ormco 27oC NiTi orthodontic archwire — DEVICE
    Placement of 0.016" Ormco 27oC NiTi orthodontic archwire
  • Device: 0.016" Ormco 35oC NiTi orthodontic archwire — DEVICE
    Placement of 0.016" Ormco 35oC NiTi orthodontic archwire

Study Details

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.

Key Dates

Start date
May 10, 2019
Status verified
May 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Pain score via Visual Analogue Score [ Time Frame: 1 hour, 4 hour, 24 hour, 4 day and 7 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado School of Dental MedicineAuroraColorado80045
Clifton Carey
[email protected]
303-724-1046

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By research site
University of Colorado School of Dental Medicine· Aurora, CO

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