RecruitingNot ApplicableNCT05639907

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


Sponsor

University of Colorado, Denver

Enrollment

30 participants

Start Date

Nov 11, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 12 Years

Inclusion Criteria3

  • Good general health, with no significant medical findings
  • 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)
  • Miniscrew pairs indicated with comparable anatomical positions and comparable mechanics (direct vs. indirect anchorage).

Exclusion Criteria5

  • Recent or ongoing use of antiresorptive pharmacological agents contraindicating the use of orthodontic miniscrews
  • Less than 12 years of age
  • Heavy tobacco use (>10 cigarettes/day)
  • Peri-implant tissues must be observable at follow-up appointments
  • Being unable or unwilling to consent to the study

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Interventions

DEVICEK21 Cavity cleanser

K21 Cavity cleanser is rinsed over the TAD and allowed to dry. The TAD is placed where needed for orthodontic therapy following the Department of Orthodontics protocols.

DEVICEEthanol control

Ethanol is rinsed over the TAD and allowed to dry. The TAD is placed where needed for orthodontic therapy following the Department of Orthodontics protocols.


Locations(1)

University of Colorado School of Dental Medicine

Aurora, Colorado, United States

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NCT05639907