search
Back to results

Comparison of Patient-reported Pain After Initial Archwire Placement (Archwires)

Primary Purpose

Orthodontic Discomfort, Pain, Orofacial

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3M Unitek 0.016 orthodontic archwire
Device: 0.016" Ormco 27oC NiTi orthodontic archwire
Device: 0.016" Ormco 35oC NiTi orthodontic archwire
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Orthodontic Discomfort focused on measuring Orthodontic, Pain

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado School of Dental MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

A: 0.016" Nitinol

B: 0.016" Ormco 27oC NiTi

C: 0.016" Ormco 35oC NiTi

Arm Description

0.016" Nitinol (3M Unitek, Monrovia, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment.

0.016" Ormco 27oC NiTi (Ormco, Glendora, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment.

0.016" Ormco 35oC NiTi (Ormco, Glendora, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 19, 2019
Last Updated
November 15, 2022
Sponsor
University of Colorado, Denver
search

1. Study Identification

Unique Protocol Identification Number
NCT03906422
Brief Title
Comparison of Patient-reported Pain After Initial Archwire Placement
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthodontic Discomfort, Pain, Orofacial
Keywords
Orthodontic, Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, triple-blind, randomized controlled clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The investigator will assemble the opaque, sealed envelopes containing the archwires. The envelopes will be labeled "A", "B" or "C" corresponding to 0.016" Nitinol (3M Unitek, Monrovia, CA), 0.016" 27o CuNiTi (Ormco, Glendora, CA) or 0.016" 35o CuNiTi (Ormco, Glendora, CA) respectively. Randomization sequences will be created by using Research Randomizer online software. The investigator will enroll patients into the study. This trial will be completed with two blocks of 63 subjects each, one block per year, with subject randomization within each block. An independent third party will maintain possession of all envelopes and distribute as needed once a subject is enrolled and ready to receive fixed orthodontic appliances. The same independent third party will maintain a log with subject identification and consent forms.
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: 0.016" Nitinol
Arm Type
Experimental
Arm Description
0.016" Nitinol (3M Unitek, Monrovia, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment.
Arm Title
B: 0.016" Ormco 27oC NiTi
Arm Type
Experimental
Arm Description
0.016" Ormco 27oC NiTi (Ormco, Glendora, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment.
Arm Title
C: 0.016" Ormco 35oC NiTi
Arm Type
Experimental
Arm Description
0.016" Ormco 35oC NiTi (Ormco, Glendora, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment.
Intervention Type
Device
Intervention Name(s)
3M Unitek 0.016 orthodontic archwire
Intervention Description
Placement of 3M Unitek 0.016 archwire for orthodontic treatment
Intervention Type
Device
Intervention Name(s)
Device: 0.016" Ormco 27oC NiTi orthodontic archwire
Intervention Description
Placement of 0.016" Ormco 27oC NiTi orthodontic archwire
Intervention Type
Device
Intervention Name(s)
Device: 0.016" Ormco 35oC NiTi orthodontic archwire
Intervention Description
Placement of 0.016" Ormco 35oC NiTi orthodontic archwire
Primary Outcome Measure Information:
Title
Pain score via Visual Analogue Score
Description
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.
Time Frame
1 hour, 4 hour, 24 hour, 4 day and 7 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clifton M Carey, PhD
Phone
303-724-1046
Email
clifton.carey@ucdenver.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Craig Shellhart, DDS
Phone
303-724-6993
Email
craig.shellhart@ucdenver.edu
Facility Information:
Facility Name
University of Colorado School of Dental Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clifton Carey
Phone
303-724-1046
Email
clifton.carey@cuanschutz.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The COMIRB approval and the consent forms specify that we cannot share PHI except as mandated by law. Therefore we do not intend to share any IPD to other researchers.
Citations:
PubMed Identifier
22259810
Citation
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.
Results Reference
background
PubMed Identifier
21856007
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.
Results Reference
background
PubMed Identifier
17488999
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.
Results Reference
background
PubMed Identifier
16000093
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.
Results Reference
background

Learn more about this trial

Comparison of Patient-reported Pain After Initial Archwire Placement

We'll reach out to this number within 24 hrs