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Archwire Types for Orthodontic Discomfort (Archwires Trial)
N/A
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 12 years or older
Requiring a minimum of 1 dental arch (first molar to first molar) labial fixed orthodontic appliance banded/bonded in 1 appointment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour, 4 hour, 24 hour, 4 day and 7 day
Awards & highlights
Archwires Trial Summary
This trial will test which of three types of 'archwires' used in Orthodontic treatment causes the least patient discomfort.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include varying levels of facial and oral pain associated with each type of archwire used in the orthodontic treatment, but no specific side effects are attributed to the wires themselves.
Archwires Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 12 years old or older.
Select...
I need braces on at least one arch of my teeth in one visit.
Select...
All my teeth can be attached to the initial braces wire.
Archwires Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 hour, 4 hour, 24 hour, 4 day and 7 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour, 4 hour, 24 hour, 4 day and 7 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Archwires Trial Design
3Treatment groups
Experimental Treatment
Group I: C: 0.016" Ormco 35oC NiTiExperimental Treatment1 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 NiTiExperimental Treatment1 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" NitinolExperimental Treatment1 Intervention
0.016" Nitinol (3M Unitek, Monrovia, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,400 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.I have taken painkillers on the same day as the bonding procedure.I need teeth removed before or right after getting braces.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.I need braces on at least one arch of my teeth in one visit.I am using medical marijuana prescribed by a doctor or recreational marijuana.All my teeth can be attached to the initial braces wire.
Research Study Groups:
This trial has the following groups:- Group 1: A: 0.016" Nitinol
- Group 2: B: 0.016" Ormco 27oC NiTi
- Group 3: C: 0.016" Ormco 35oC NiTi
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings for this investigation at the present?
"Affirmative. According to the information hosted on clinicaltrials.gov, this trial commenced recruiting patients since May 10th 2019 and will continue until November 15th 2022. The medical study is looking for 126 participants from one centre."
Answered by AI
How many participants are being admitted to this research endeavor?
"Affirmative. As evidenced on clinicaltrials.gov, this medical research is actively seeking volunteers; the trial was first announced on May 10th 2019 and its conditions were recently amended on November 15th 2022 for a total of 126 participants across one location."
Answered by AI
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