Orthodontic DiscomfortArchwiresNCT03906422
Comparison of Patient-reported Pain After Initial Archwire Placement
A study testing 3M Unitek 0.016 orthodontic archwire, Device: 0.016" Ormco 27oC NiTi orthodontic archwire and Device: 0.016" Ormco 35oC NiTi orthodontic archwire in people with Orthodontic Discomfort and Pain, Orofacial, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Discomfort, Pain, Orofacial
- What is being tested?
- 3M Unitek 0.016 orthodontic archwire, Device: 0.016" Ormco 27oC NiTi orthodontic archwire and Device: 0.016" Ormco 35oC NiTi orthodontic archwire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2019to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado School of Dental Medicine
Aurora, Colorado, 80045
Clifton Carey, 303-724-1046, clifton.carey@cuanschutz.edu
About this study
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
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.
Read the 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
- Being tested
- 3M Unitek 0.016 orthodontic archwire, Device: 0.016" Ormco 27oC NiTi orthodontic archwire, Device: 0.016" Ormco 35oC NiTi orthodontic archwire
- Keywords
- Orthodontic, Pain
- Medical subject headings
- Facial Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M Unitek 0.016 orthodontic archwireDevice
Placement of 3M Unitek 0.016 archwire for orthodontic treatment
Device: 0.016" Ormco 27oC NiTi orthodontic archwireDevice
Placement of 0.016" Ormco 27oC NiTi orthodontic archwire
Device: 0.016" Ormco 35oC NiTi orthodontic archwireDevice
Placement of 0.016" Ormco 35oC NiTi orthodontic archwire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Device: 0.016" Ormco 35oC NiTi orthodontic archwire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour, 4 hour, 24 hour, 4 day and 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start10 May 2019
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Orthodontic DiscomfortStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, triple-blind, randomized controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906422
- Sponsor's protocol ID
- 18-1737
- Acronym
- Archwires
- Status last verified
- May 2026
- First submitted
- 19 Mar 2019
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 22259810Graf 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.
PubMed 21856007Krishnan V. Orthodontic pain: from causes to management--a review. Eur J Orthod. 2007 Apr;29(2):170-9. doi: 10.1093/ejo/cjl081.
PubMed 17488999Williamson 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.
PubMed 16000093
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03906422
- Acronym / sponsor ID
- Archwires / 18-1737
- Conditions
- Orthodontic Discomfort, Pain, Orofacial
- Keywords
- Orthodontic, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- prospective, triple-blind, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| A: 0.016" Nitinol | Experimental | Device: 3M Unitek 0.016 orthodontic archwire0.016" Nitinol (3M Unitek, Monrovia, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment. |
| B: 0.016" Ormco 27oC NiTi | Experimental | Device: Device: 0.016" Ormco 27oC NiTi orthodontic archwire0.016" Ormco 27oC NiTi (Ormco, Glendora, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment. |
| C: 0.016" Ormco 35oC NiTi | Experimental | Device: Device: 0.016" Ormco 35oC NiTi orthodontic archwire0.016" Ormco 35oC NiTi (Ormco, Glendora, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3M Unitek 0.016 orthodontic archwirePlacement of 3M Unitek 0.016 archwire for orthodontic treatment | Device | A: 0.016" Nitinol |
| Device: 0.016" Ormco 27oC NiTi orthodontic archwirePlacement of 0.016" Ormco 27oC NiTi orthodontic archwire | Device | B: 0.016" Ormco 27oC NiTi |
| Device: 0.016" Ormco 35oC NiTi orthodontic archwirePlacement of 0.016" Ormco 35oC NiTi orthodontic archwire | Device | C: 0.016" Ormco 35oC NiTi |
Primary outcome
Pain score via Visual Analogue Score
Time frame: 1 hour, 4 hour, 24 hour, 4 day and 7 day
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 22259810Cioffi 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.
- Background: PubMed 21856007Graf 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.
- Background: PubMed 17488999Krishnan V. Orthodontic pain: from causes to management--a review. Eur J Orthod. 2007 Apr;29(2):170-9. doi: 10.1093/ejo/cjl081.
- Background: PubMed 16000093Williamson 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.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3M Unitek 0.016 orthodontic archwire, Device: 0.016" Ormco 27oC NiTi orthodontic archwire and Device: 0.016" Ormco 35oC NiTi orthodontic archwire in people with Orthodontic Discomfort and Pain, Orofacial, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clifton M Carey, PhD (303-724-1046, clifton.carey@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score via Visual Analogue Score (time frame: 1 hour, 4 hour, 24 hour, 4 day and 7 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03906422, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.