Comparing K21 and Ethanol Coatings on Orthodontic Miniscrews
Official title: A Comparison of Miniscrew Stability and Peri-implant Inflammation When Precoated With Antimicrobial Quaternary Ammonium Compound K21 vs Ethanol Control in Orthodontic Patients: a Triple-blind, Split-mouth, Randomized Controlled Clinical Trial
Run by University of Colorado, Denver · NCT05639907 · Data updated 2026-11-12
This study is testing if a new K21 coating on orthodontic miniscrews can reduce inflammation better than a standard ethanol coating during orthodontic treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | November 11, 2022 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT05639907 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals in good general health who require at least two orthodontic miniscrews as part of their treatment plan.
✕Probably not a fit
Patients who are under 12 years of age, have significant medical issues, or are heavy tobacco users may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of K21 coating on orthodontic miniscrews in reducing inflammation compared to an ethanol control. It employs a split-mouth design where participants receive two miniscrews, one coated with K21 and the other with ethanol, during their orthodontic treatment. The stability of the miniscrews will be assessed at 4 and 8 weeks post-placement, along with signs of peri-implant inflammation. Success is defined by the maintenance of stability and absence of significant inflammation in the surrounding tissue.
Why it matters
Potential benefit: If successful, this study could lead to improved stability of orthodontic miniscrews and reduced inflammation, enhancing patient comfort and treatment outcomes.
How similar studies have gone: While the specific use of K21 in this context may be novel, similar studies have shown that modifications to miniscrew coatings can impact stability and inflammation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Good general health, with no significant medical findings 2. Requiring at least two miniscrews in their treatment plans (i.e., most participants will have two miniscrews, but some may receive four or six as indicated by their individual treatment plan) 3. Miniscrew pairs indicated with comparable anatomical positions and comparable mechanics (direct vs. indirect anchorage). Exclusion Criteria: 1. Recent or ongoing use of antiresorptive pharmacological agents contraindicating the use of orthodontic miniscrews 2. Less than 12 years of age 3. Heavy tobacco use (\>10 cigarettes/day) 4. Peri-implant tissues must be observable at follow-up appointments 5. Being unable or unwilling to consent to the study
Where it's running
-
University of Colorado School of Dental Medicine
Aurora, Colorado, United States Recruiting
Study contacts
- Study coordinator: Clifton M Carey, PhD
- Email: clifton.carey@cuanschutz.edu
- Phone: 3037241046
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.