NCT05639907NARecruitingAccepts Healthy Volunteers

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

University of Colorado, Denver

Start Date

11/11/2022

Completion Date

6/1/2028

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.

Eligibility Criteria

Age Range: 12 years to No maximum

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

Interventions

DEVICE

K21 Cavity cleanser

DEVICE

Ethanol control

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Conditions

Inflammation Caused by the Placement of a Temporary Anchorage Device

Locations

University of Colorado School of Dental Medicine

Aurora, Colorado 80045

United States