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

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Inflammation Caused by the Placement of a Temporary Anchorage Device

Treatments: Device: K21 Cavity cleanser; Device: Ethanol control

Study type: Interventional

Funder types: Other

Identifiers

NCT05639907

22-1579

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

K21 Cavity cleanser-coated TAD

Experimental group

Description:

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.

Treatment:

Device: K21 Cavity cleanser

Ethanol Control

Placebo Comparator group

Description:

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.

Treatment:

Device: Ethanol control