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Miniscrew Stability and Peri-implant Inflammation When Precoated K21 vs Ethanol Control

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

Who can join

Ages 12 and older · All sexes · Healthy volunteers welcome

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

About the study

To determine if coating miniscrews with K21 would increase the success rate of orthodontic miniscrews by reducing adjacent tissue inflammation.

What is being tested

• K21 Cavity cleanser (device)
• Ethanol control (device)

Sponsor: University of Colorado, Denver · Participants: 30 · Started: Nov 11, 2022

Contact the study team

• Clifton M Carey, PhD · Phone: 3037241046
• Gerald Minick, DDS · Phone: 3037247830

Official record on ClinicalTrials.gov — NCT05639907

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.