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K21 Coating for Miniscrew Stability and Peri-implant Inflammation

N/A

Recruiting

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study Summary

This trial tested if coating miniscrews with K21 would help orthodontic miniscrews stay in place better by reducing irritation to surrounding tissue.

Who is the study for?

This trial is for healthy individuals who need at least two miniscrews as part of their orthodontic treatment. Participants should have similar anatomical positions and mechanics indicated for each pair of miniscrews.Check my eligibility

What is being tested?

The study is testing if K21 cavity cleanser coating on miniscrews can reduce inflammation and increase success rates compared to a standard ethanol control in patients undergoing orthodontic treatments.See study design

What are the potential side effects?

Potential side effects may include local inflammation or irritation around the implant site, but specific side effects related to K21 are not detailed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Peri-implant inflammation

TAD motility

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: K21 Cavity cleanser-coated TADExperimental Treatment1 Intervention

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.

Group II: Ethanol ControlPlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,496 Total Patients Enrolled

19 Trials studying Inflammation

2,078 Patients Enrolled for Inflammation

Media Library

Ethanol control (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05639907 — N/A

Inflammation Research Study Groups: K21 Cavity cleanser-coated TAD, Ethanol Control

Inflammation Clinical Trial 2023: Ethanol control Highlights & Side Effects. Trial Name: NCT05639907 — N/A

Ethanol control (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05639907 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is access to this research trial currently available for participants?

"According to clinicaltrials.gov, this research initiative is currently recruiting for participants. It was first published on November 11th 2022 and most recently revised on May 10th of 2023."

Answered by AI

How many participants are included in the current clinical trial?

"Affirmative. According to the data present on clinicaltrials.gov, this clinical trial is actively recruiting patients at a single location and has been doing so since November 11th 2022. The study requires 30 participants in total with its last update being May 10th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Miniscrew Stability and Peri-implant Inflammation When Precoated K21 vs Ethanol Control". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05639907.