Archwire Types for Orthodontic Discomfort
(Archwires Trial)
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.12345
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.12567
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.15689
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one of three types of nickel-titanium archwires at the initial bonding appointment
Follow-up
Participants are monitored for changes in pain levels using the Visual Analogue Score (VAS) over the first week after archwire insertion
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
0.016" Ormco 27oC NiTi orthodontic archwire is already approved in United States, European Union, Canada for the following indications:
- Orthodontic treatment for malocclusion
- Tooth alignment and leveling
- Orthodontic treatment for malocclusion
- Tooth alignment and leveling
- Orthodontic treatment for malocclusion
- Tooth alignment and leveling
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor