Archwire Types for Orthodontic Discomfort

(Archwires Trial)

Overseen By Clifton M Carey, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Sulfonamides, MAO inhibitors, Tricyclics, Phenothiazines

Disqualifiers: Metal allergies, Under 12, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which of three different orthodontic wires causes the least discomfort for patients. All three wires are commonly used and equally effective, but they might differ in comfort when worn. Participants will receive one of the three wire types, including the 0.016" Ormco 27oC NiTi orthodontic archwire, at the start of their orthodontic treatment. The trial seeks individuals who are healthy, need braces on at least one dental arch, and do not have any nickel allergies. As an unphased trial, this study allows participants to contribute to improving orthodontic comfort for future patients.

Will I have to stop taking my current medications?

If you are currently taking sulfonamides, monoamine oxidase inhibitors, tricyclic antidepressants, phenothiazines, or medical marijuana, you will need to stop before joining the trial.

What prior data suggests that these archwires are safe for orthodontic treatment?

Research has shown that the three types of wires used in braces are generally safe for people. One study found that superelastic nickel-titanium wires might cause more pain in the first 24 hours compared to other wires, but there is no significant difference in long-term discomfort among the different types. This suggests any pain is usually temporary.

For the 0.016" Ormco 27°C and 35°C nickel-titanium wires, studies have shown they effectively straighten teeth without causing major problems. Some research mentions these wires might be more prone to tiny surface pits, but this typically doesn't lead to issues for patients.

Overall, these wires are well-tolerated, and any discomfort usually resolves quickly. The trial aims to determine if one type of wire causes less discomfort than the others, but all three are considered safe based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these orthodontic archwires because they offer a potentially more comfortable experience for patients during initial braces placement, a time typically associated with discomfort. Unlike traditional nickel-titanium (NiTi) archwires that often activate at body temperature, the 0.016" Ormco 27°C and 35°C NiTi archwires are designed to activate at specific, lower temperatures, potentially providing a gentler force on teeth. The 3M Unitek 0.016" Nitinol archwire, also part of the study, is known for its flexibility and consistent force application, potentially reducing pain. These innovative materials and their unique activation properties make them stand out against standard archwires used in orthodontics, sparking interest in their ability to improve patient comfort and treatment outcomes.

What evidence suggests that these archwires could be effective for reducing orthodontic discomfort?

Research has shown that all three types of orthodontic wires in this trial—0.016" Ormco 27°C NiTi, 0.016" Ormco 35°C NiTi, and 3M Unitek 0.016"—are equally effective in straightening teeth. Studies with orthodontic patients have found no significant differences in their effectiveness for improving tooth alignment. For instance, one study found that both NiTi and Cu-NiTi wires improved alignment over six weeks without major differences. Another study supported these findings, showing no significant differences in timing or effectiveness among different flexible nickel-titanium wires. This trial focuses on determining which wire causes the least discomfort for patients, rather than differences in effectiveness. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy individuals aged 12 or older who need orthodontic treatment with fixed appliances across at least one dental arch. Participants should not have metal allergies, be on certain medications like antidepressants, or use marijuana. Any necessary dental extractions must occur 3 weeks before or after the appliance is fitted.

Inclusion Criteria

Healthy, with no significant systemic diseases or complications or special needs

I am 12 years old or older.

I have completed any dental extractions for my braces at least 3 weeks before or will do so after getting them.

Exclusion Criteria

I am under 12 years old.

You are allergic to nickel.

I am currently taking or have recently taken certain medications like sulfonamides or antidepressants.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive one of three types of nickel-titanium archwires at the initial bonding appointment

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain levels using the Visual Analogue Score (VAS) over the first week after archwire insertion

1 week

Multiple assessments (1 hour, 4 hour, 24 hour, 4 day, 7 day)

What Are the Treatments Tested in This Trial?

Interventions

• 0.016" Ormco 27oC NiTi orthodontic archwire
• 0.016" Ormco 35oC NiTi orthodontic archwire
• 3M Unitek 0.016 orthodontic archwire
• Initial Archwire Placement

Trial Overview The study tests three types of orthodontic 'archwires' to see which causes the least discomfort during treatment. The type of wire used will be chosen by the treating Orthodontist without any bias towards effectiveness as all are considered equally effective.

How Is the Trial Designed?

Group I: C: 0.016" Ormco 35oC NiTi Experimental Treatment 1 Intervention

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

Group II: B: 0.016" Ormco 27oC NiTi Experimental Treatment 1 Intervention

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

Group III: A: 0.016" Nitinol Experimental Treatment 1 Intervention

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 orthodontic archwire is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ormco NiTi archwire for:

• Orthodontic treatment for malocclusion
• Tooth alignment and leveling

Approved in European Union as Ormco NiTi archwire for:

• Orthodontic treatment for malocclusion
• Tooth alignment and leveling

Approved in Canada as Ormco NiTi archwire for:

• Orthodontic treatment for malocclusion
• Tooth alignment and leveling

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

In an in-vitro study, three types of Nickel-Titanium (NiTi) archwires were tested for corrosion resistance against fluoride mouthwashes, revealing that all wires were passive in artificial saliva but showed decreased corrosion resistance with higher fluoride concentrations.

While fluoride exposure negatively impacted the corrosion properties of NiTi archwires, they were still more resistant to corrosion compared to stainless steel archwires, suggesting that NiTi may be a better choice for orthodontic treatments involving fluoride use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of fluoride on nickel-titanium and stainless steel orthodontic archwires: an in-vitro study. Heravi, F., Moayed, MH., Mokhber, N.[2020]

A clinical trial involving 42 orthodontic patients showed that nickel-titanium (NiTi) archwires significantly increase nickel levels in saliva after 2 months of treatment, with a notable rise from 10.46 to 11.08 μg/L.

Among different types of archwires, epoxy-coated NiTi released the least nickel, followed by copper NiTi, indicating that these newer materials may be safer options for reducing nickel exposure compared to conventional NiTi archwires.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Fixed Orthodontic Treatment Using Conventional, Copper-Included, and Epoxy-Coated Nickel-Titanium Archwires on Salivary Nickel Levels: A Double-Blind Randomized Clinical Trial. Khaneh Masjedi, M., Niknam, O., Haghighat Jahromi, N., et al.[2022]

In a study involving 128 orthodontic patients, the superelastic nickel-titanium archwire (Sentalloy) caused less pain and discomfort compared to the conventional nickel-titanium archwire (Nitinol) during the first 10 hours after placement, with a significant difference noted at 4 hours.

Patients experienced increasing discomfort after the insertion of either archwire, peaking on the first night and remaining elevated on the second day, but returning to baseline levels by day 7; additionally, discomfort was greater in the lower dental arch compared to the upper arch.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain and discomfort experienced after placement of a conventional or a superelastic NiTi aligning archwire. A randomized clinical trial. Fernandes, LM., Ogaard, B., Skoglund, L.[2022]

Both 0.016-inch superelastic and heat-activated nickel-titanium archwires demonstrated similar efficiency in aligning teeth during orthodontic treatment, with no significant difference in alignment outcomes (p = 0.45).

Patients using superelastic NiTi archwires reported significantly higher pain levels compared to those using heat-activated NiTi archwires at both 24 hours and one week after placement (p < 0.05), although both types resulted in similar levels of root resorption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of two different initial archwires for tooth alignment during fixed orthodontic treatment-A randomized clinical trial. Jain, S., Sharma, P., Shetty, D.[2021]

Nickel-titanium archwires, specifically the superelastic (PSE) type, initially show superior mechanical properties compared to traditional (TE) archwires, including higher load at fracture and ultimate tensile strength, based on a study of 24 archwires tested under controlled conditions.

After 3 months of clinical use, both types of archwires experienced a significant decrease in mechanical properties, indicating reduced resistance to breakage, although the initial differences in performance between PSE and TE wires remained consistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in the mechanical properties of two nickel-titanium archwires after 3 months of clinical usage. Amaya, S., Pérez, A., Guzmán, H., et al.[2021]

In a study involving 88 orthodontic patients, both A-NiTi and Cu-NiTi archwires were found to be equally effective in improving tooth alignment over a 6-week treatment period, with no significant differences in the reduction of irregularity index.

Pain levels, duration of pain, and analgesic intake were similar for both archwire types, indicating that neither type caused more discomfort during orthodontic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tooth alignment and pain experience with A-NiTi versus Cu-NiTi: a randomized clinical trial. Azizi, F., Extiari, A., Imani, MM.[2021]

Heat-activated NiTi archwires generally require less force to deactivate compared to superelastic NiTi archwires, making them potentially more suitable for biological applications in orthodontics.

Among the tested archwires, the CuNiTi 27°C archwires showed the lowest deactivation loadings, while the CuNiTi 35°C archwires had less favorable mechanical behavior, indicating that temperature affects the performance of these materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical properties of NiTi and CuNiTi shape-memory wires used in orthodontic treatment. Part 1: stress-strain tests. Gravina, MA., Brunharo, IH., Canavarro, C., et al.[2022]

In a study involving 154 patients aged 10 to 17, no significant differences were found in patient discomfort or root resorption among three different orthodontic archwire sequences, indicating similar safety and efficacy across the treatments.

Sequence B required more visits to reach the working archwire compared to Sequence A, suggesting that the choice of archwire sequence can impact treatment efficiency, even though the discomfort levels remained consistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which orthodontic archwire sequence? A randomized clinical trial. Mandall, N., Lowe, C., Worthington, H., et al.[2022]

At small activations (20-30 degrees), nickel-titanium (NiTi) orthodontic archwires exhibit stiffness similar to that of stainless steel (Tru-chrome) archwires, making them effective for initial adjustments.

However, at larger activations (35 degrees and above), nickel-titanium wires demonstrate significantly lower stiffness, with only 56% and 43% of the stiffness of stainless steel, which may impact their effectiveness in more demanding orthodontic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A comparison of archwires of memory alloys Nitinol, NiTi Ormco and Tru-chrome which were subjected to edgewise torsion of 20 degrees, 25 degrees, 30 degrees and 35 degrees and a temperature of 37 degrees Celsius]. Filleul, MP.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03906422?cond=Archwire&aggFilters=status:not%20rec%20ava&viewType=Table&rank=1

Comparison of Patient-reported Pain After Initial Archwire ... 0.016" Ormco 27oC NiTi (Ormco, Glendora, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment. Intervention/Treatment ...

2. withpower.com withpower.com/trial/phase-facial-pain-4-2019-0d4fa

Archwire Types for Orthodontic Discomfort In a study involving 88 orthodontic patients, both A-NiTi and Cu-NiTi archwires were found to be equally effective in improving tooth alignment over a 6-week ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11853181/

Influence of orthodontic archwire (nickel–titanium versus ... The aim of this pilot study was to analyze the influence of a nickel–titanium archwire (NiTi) and a copper–nickel–titanium archwire (Cu-NiTi) on pain levels in ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2215098622001860

Nickel titanium alloys as orthodontic archwires: A narrative ... Nickel-titanium (NiTi) archwires have been widely used in orthodontic treatments at the aligning and leveling step which is the initial stage of the treatment.

5. researchgate.net researchgate.net/publication/389318404_Influence_of_orthodontic_archwire_nickel-titanium_versus_copper-nickel-titanium_on_pain_in_adult_patients_in_the_aligning_phase_of_treatment_with_self-ligating_brackets_two_months_of_follow-up_a_prosp

Influence of orthodontic archwire (nickel-titanium versus ... This study analyzed 30 adult orthodontic patients who began treatment with self-ligating brackets. The participants were distributed into two ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4078986/

A randomized clinical trial investigating pain associated ... The study found no overall pain difference, but superelastic nickel-titanium wires caused greater pain at 12 hours and on day 1 compared to stainless steel ...

7. solventum.com solventum.com/en-us/home/f/b10070635/

3M™ Unitek™ Nitinol Classic Archwire This "Classic" archwire continues to provide the linear elasticity and bendability of high strength steel and the elastic working range and lighter forces.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8423150/

Comparison of two different initial archwires for tooth ... The study found no significant difference in alignment efficiency between the two archwires, but superelastic NiTi wires caused more pain.

9. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6187909&pc=DZC

MAUDE Adverse Event Report: 3M UNITEK CORPORAION ... The orthodontic wire was placed in (b)(6) 2016.The wire was excreted in the patients stool without incident.While no injury occurred, this event is being ...