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

University of Colorado, Denver30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Inflammation Caused by the Placement of a Temporary Anchorage Device

Interventions

K21 Cavity cleanserDEVICE

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 controlDEVICE

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.

Eligibility

Sex: ALLMin age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Colorado School of Dental Medicine

Aurora, Colorado, United States

RECRUITING

Outcomes

Primary Outcomes

TAD motility

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.

Time frame: 8 weeks

Peri-implant inflammation

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.

Time frame: 8 weeks

Central Contacts

Clifton M Carey, PhD

CONTACT

3037241046 clifton.carey@cuanschutz.edu

Gerald Minick, DDS

CONTACT

3037247830 gerald.minick@cuanschutz.edu

Data from ClinicalTrials.gov

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