Trials
Search / Trial NCT05639907

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

Launched by UNIVERSITY OF COLORADO, DENVER · Dec 2, 2022

Trial Information

Current as of January 14, 2025

Recruiting

Keywords

Tad Inflammation Orthodontics

ClinConnect Summary

This clinical trial is studying whether coating orthodontic miniscrews with a special material called K21 can help reduce inflammation in the tissue around the screws. The goal is to see if this coating can improve the success rate of these temporary devices, which are often used in orthodontic treatments to help move teeth. The trial is currently recruiting participants who are generally healthy and need at least two miniscrews as part of their treatment plan.

To be eligible for the study, participants must be at least 12 years old and not have certain health issues, such as recent use of specific medications or heavy tobacco use. If you join the trial, you can expect to have both coated and uncoated miniscrews placed during your treatment, and you’ll be monitored for any inflammation around these devices. This research could help improve orthodontic treatments for many patients in the future.

Gender

ALL

Eligibility criteria

  • 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

About University Of Colorado, Denver

The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.

Locations

Aurora, Colorado, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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