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Outcome Measures

Primary Outcomes (1)

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.
1 hour, 4 hour, 24 hour, 4 day and 7 day

Study Arms (3)

A: 0.016" Nitinol

EXPERIMENTAL

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

Device: 3M Unitek 0.016 orthodontic archwire

B: 0.016" Ormco 27oC NiTi

EXPERIMENTAL

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

Device: Device: 0.016" Ormco 27oC NiTi orthodontic archwire

C: 0.016" Ormco 35oC NiTi

EXPERIMENTAL

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

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Related Publications (4)

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.

PMID: 22259810BACKGROUND

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.

PMID: 21856007BACKGROUND

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

QUADRUPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR

Masking Details

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.

Purpose

OTHER

Intervention Model

PARALLEL

Model Details: prospective, triple-blind, randomized controlled clinical trial

Sponsor Type

OTHER

Responsible Party

SPONSOR

Comparison of Patient-reported Pain After Initial Archwire Placement

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

A: 0.016" Nitinol

B: 0.016" Ormco 27oC NiTi

C: 0.016" Ormco 35oC NiTi

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

A: 0.016" Nitinol

B: 0.016" Ormco 27oC NiTi

C: 0.016" Ormco 35oC NiTi

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations