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

Trial Summary

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 data supports the effectiveness of the treatment 0.016" Ormco 27oC NiTi orthodontic archwire for orthodontic discomfort?

Research shows that nickel-titanium (NiTi) archwires, like the 0.016" Ormco 27oC NiTi, are commonly used for initial tooth alignment in orthodontic treatment and are effective in aligning teeth with manageable levels of discomfort. Studies comparing different types of NiTi archwires indicate that they provide similar levels of pain and alignment efficiency, suggesting their effectiveness in orthodontic treatment. ^{1 2 3 4 5}

Is the use of nickel-titanium (NiTi) orthodontic archwires generally safe for humans?

Nickel-titanium (NiTi) archwires are commonly used in orthodontic treatments and are generally considered safe, but they can increase nickel levels in saliva, which might be a concern for people with nickel allergies. Some types of NiTi archwires, like epoxy-coated ones, release less nickel compared to conventional ones. ^{1 2 5 6 7}

How does the treatment with different types of NiTi orthodontic archwires differ from other treatments for orthodontic discomfort?

The treatment using different types of nickel-titanium (NiTi) orthodontic archwires, such as the Ormco 27°C and 35°C NiTi archwires, is unique because these wires are designed to provide consistent and gentle force for tooth alignment, which can reduce discomfort compared to other materials. Additionally, the inclusion of copper in some NiTi archwires can further modify their mechanical properties, potentially offering a more comfortable experience by releasing less nickel into saliva. ^{1 5 6 8 9}

What is the purpose of this 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.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Tooth alignment and pain experience with A-NiTi versus Cu-NiTi: a randomized clinical trial. [2021]

2. Brazil pubmed.ncbi.nlm.nih.gov

Mechanical properties of NiTi and CuNiTi shape-memory wires used in orthodontic treatment. Part 1: stress-strain tests. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Comparison of two different initial archwires for tooth alignment during fixed orthodontic treatment-A randomized clinical trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Which orthodontic archwire sequence? A randomized clinical trial. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Pain and discomfort experienced after placement of a conventional or a superelastic NiTi aligning archwire. A randomized clinical trial. [2022]

6. United States 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. [2022]

7. Iran pubmed.ncbi.nlm.nih.gov

Effect of fluoride on nickel-titanium and stainless steel orthodontic archwires: an in-vitro study. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Changes in the mechanical properties of two nickel-titanium archwires after 3 months of clinical usage. [2021]

9. France 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]. [2016]