NCT05639907

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

The study design is a split mouth study where 2 miniscrews, one pretreated with K21 the other pretreated (experimental) with ethanol (placebo) are placed in the mouth for orthodontic therapy. All participants will receive 2 or more orthodontic miniscrews with equal numbers of experimental and control pretreatment solutions. Mobility will be assessed at the 4 and 8 week follow up appointments by gentle manipulation with cotton pliers. Clinical success will be defined as maintenance of stability for a period of 8 weeks. Peri-implant inflammation will be assessed at follow up appointments by looking for signs of soft-tissue inflammation (redness, swelling) where possible.

Conditions

• Inflammation Caused by the Placement of a Temporary Anchorage Device

Interventions

Type	Name	Description
DEVICE	K21 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.
DEVICE	Ethanol 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.

Timeline

• Start date: 2022-11-11
• Primary completion: 2027-06-01
• Completion: 2028-06-01
• First posted: 2022-12-07
• Last updated: 2025-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study