Recruiting

K21

Sponsor:

University of Colorado, Denver

Code:

NCT05639907

Conditions

Inflammation Caused by the Placement of a Temporary Anchorage Device

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Interventions

K21 Cavity cleanser

Ethanol control

Study Details

Brief summary:

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

Conditions

Inflammation Caused by the Placement of a Temporary Anchorage Device

Study ID

NCT05639907

Start date

Nov 11, 2022

Status verified date

May, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: K21 Cavity cleanser-coated TAD

A TAD to be placed is coated with K21 solution. The solution is allowed to evaporate to dryness, leaving a K21-rich film. The TAD is placed following the University TAD placement protocol.

placebo comparator: Ethanol Control

A TAD to be placed is coated with ethanol solution. The solution is allowed to evaporate to dryness (no residue is expected). The TAD is placed following the University TAD placement protocol.

Interventions

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.

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.

Primary outcome measure

  • TAD motility [ Time Frame: 8 weeks ]
  • Peri-implant inflammation [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Clifton M Carey, PhD

3037241046clifton.carey@cuanschutz.edu

Gerald Minick, DDS

3037247830gerald.minick@cuanschutz.edu

Locations

University of Colorado School of Dental Medicine

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Clifton Carey, PhD

303-724-1046clifton.carey@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • TAD
  • inflammation
  • orthodontics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-05-14.