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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05639907
Collaborator
(none)
30
Enrollment
2
Arms
29
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: K21 Cavity cleanser
  • Device: Ethanol control
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Split mouthSplit mouth
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
There will be random allocation established, such that as a study participant is enrolled the clinician will receive a numbered envelope that contains the information for which TAD placement site will receive a TAD coated with solution A or B. The identification of Solution A or B is kept secret in an envelope stored in the office of the Chair of the Orthodontic Department (U Colo, Sch Dent Med). The patient, clinical operator, Investigator and Outcomes assessor is not aware which solution (A or B) is the experimental or placebo.
Primary Purpose:
Prevention
Official Title:
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
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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.

Device: 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.
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.

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. TAD motility [8 weeks]

    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.

  2. Peri-implant inflammation [8 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Colorado, Denver

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT05639907
Other Study ID Numbers:
  • 22-1579
First Posted:
Dec 7, 2022
Last Update Posted:
Dec 7, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by University of Colorado, Denver
TAD
inflammation
orthodontics
Additional relevant MeSH terms:
Inflammation
Ethanol

Study Results

No Results Posted as of Dec 7, 2022