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NCT Number: NCT05639907

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

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

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado School of Dental Medicine

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Clifton Carey, PhD

CONTACT

[email protected]

303-724-1046

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

K21 Cavity cleanser

Device

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.

Ethanol control

Device

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.

Primary outcomes

  1. TAD motility

    Time frame: 8 weeks

    The motility of a TAD is evaluated by gentle manipulation with cotton pliers. Clinical failures will be defined as a mobility greater than or equal to 1mm. Clinical success will be defined as maintenance of stability for a period of 8 weeks.

  2. Peri-implant inflammation

    Time frame: 8 weeks

    Inspection for signs of soft-tissue inflammation (redness, swelling) immediately around the TAD. The Loe-Silness Index scale will be used to assess any inflammation. The Loe-Silness Index scale is between 0 and 3 where a 0 is normal soft tissue, 1 is mild inflammation where the tissue color is slightly red and the tissue does not bleed upon probing, 2 is moderate inflammation where the tissue color is red with edema and bleeds upon probing, and 3 is severe inflammation where the tissue bleeds with little or no probing has edema and has ulcers.

Study contacts

Contact information is provided by the study sponsor or research team.

Clifton M Carey, PhD

CONTACT

[email protected]

3037241046

Gerald Minick, DDS

CONTACT

[email protected]

3037247830

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Dec 7, 2022
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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