Comparing pain levels from different orthodontic archwires
Comparison of Patient-reported Pain After Initial Archwire Placement With Three Types of Nickel-titanium Archwires: a Prospective Triple-blind, Randomized Controlled Clinical Trial
NA · University of Colorado, Denver · NCT03906422
This study is testing which type of orthodontic archwire causes the least discomfort for patients getting braces.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT03906422 on ClinicalTrials.gov |
What this trial studies
This study evaluates the discomfort experienced by patients undergoing orthodontic treatment with three different types of nickel-titanium archwires. The research aims to determine if one type of archwire causes less pain than the others, as previous studies have shown conflicting results regarding pain levels. Participants will be monitored for pain levels after the initial placement of the archwires, which are commonly used for aligning teeth. The findings could help orthodontists make more informed decisions about wire selection to enhance patient comfort.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 12 years or older who require orthodontic treatment with fixed appliances.
Not a fit: Patients with metal allergies or those currently taking specific medications for pain management may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient comfort during orthodontic treatment by identifying the least painful archwire option.
How similar studies have performed: While previous studies have explored pain levels associated with orthodontic archwires, this specific comparison has not been extensively tested, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy, with no significant systemic diseases or complications or special needs 2. Requiring a minimum of 1 dental arch (first molar to first molar) labial fixed orthodontic appliance banded/bonded in 1 appointment 3. All banded/bonded teeth can be ligated to initial archwire (no severely displaced or blocked out teeth). 4. 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. 5. Age 12 years or older Exclusion Criteria: 1. Currently taking or recently taken sulfonamides, monoamine oxidase inhibitors, tricyclic antidepressants, or phenothiazines 2. Currently taking physician-prescribed medical marijuana for the management of pain or recreational marijuana during the trial period 3. Metal-type (Nickel) allergies 4. Less than 12 years old 5. Same day use of analgesics prior to bonding 6. Treatment requiring dental extractions prior to or immediately after bonding of fixed appliance
Where this trial is running
Aurora, Colorado
- University of Colorado School of Dental Medicine — Aurora, Colorado, United States (RECRUITING)
Study contacts
- Study coordinator: Clifton M Carey, PhD
- Email: clifton.carey@ucdenver.edu
- Phone: 303-724-1046
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Orthodontic Discomfort, Pain, Orofacial, Orthodontic, Pain