Comparing K21 and Ethanol Coatings on Orthodontic Miniscrews
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05639907 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals in good general health who require at least two orthodontic miniscrews as part of their treatment plan.
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.
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 performed: 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.
Eligibility criteria
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 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@cuanschutz.edu
- Phone: 3037241046
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.