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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Inflammation Caused by the Placement of a Temporary Anchorage Device

Intervention / Treatment
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* Device: K21 Cavity cleanser
* Device: Ethanol control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split mouth
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K21 Cavity cleanser-coated TAD<br>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. | Device: K21 Cavity cleanser<br>* 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.<br>|
| Placebo Comparator: Ethanol Control<br>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. | Device: Ethanol control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAD, inflammation, orthodontics