K21 Coating for Miniscrew Stability and Peri-implant Inflammation

Overseen By Gerald Minick, DDS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Antiresorptive agents

Disqualifiers: Under 12, Heavy tobacco use, others

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if coating orthodontic miniscrews with K21 can enhance their effectiveness by reducing inflammation (swelling and irritation) around the screws. Participants will receive either miniscrews coated with K21 (an antimicrobial cavity cleanser) or a regular ethanol coating to compare the effects. The trial seeks healthy individuals who require at least two miniscrews for their dental treatment. As an unphased trial, it offers participants the chance to contribute to innovative dental research that could improve future treatments.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain bone-related medications that interfere with miniscrews.

What prior data suggests that the K21 coating is safe for miniscrew use?

Research has shown that K21 Cavity Cleanser was well-tolerated in previous studies. It primarily cleans cavities and effectively kills germs. Importantly, studies have found that it does not weaken dental adhesives, which benefits dental procedures. Although limited safety data exists specifically for its use on miniscrews, its past use in dental settings offers some reassurance.

The current trial explores how K21 might reduce inflammation around miniscrews. Safety information from its dental use suggests it is not linked to significant negative effects. This background can reassure potential participants considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the K21 Cavity cleanser because it offers a novel approach to enhancing miniscrew stability and reducing peri-implant inflammation. Unlike traditional treatments that may focus solely on mechanical stability or general antibacterial measures, the K21 solution creates a K21-rich film on the temporary anchorage device (TAD) once applied and dried. This film potentially provides both enhanced stability and targeted anti-inflammatory effects, which could lead to better outcomes in dental procedures requiring TADs. By directly addressing inflammation at the site, K21 may improve patient comfort and implant longevity compared to standard methods.

What evidence suggests that the K21 coating is effective for improving miniscrew stability and reducing peri-implant inflammation?

Research has shown that the K21 cavity cleanser, which participants in this trial may receive, might reduce swelling and improve the success of orthodontic miniscrews. Studies have found that it can kill germs, lowering bacteria and swelling around dental implants. K21 penetrates bacterial walls, potentially preventing infections. As an effective cavity cleanser, it proves useful for dental care. These findings suggest that K21 could help miniscrews remain stable by keeping the surrounding area free from bacteria and swelling. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Good general health, with no significant medical findings

My treatment plan includes using at least two miniscrews.

My dental treatment involves similarly placed miniscrews.

Exclusion Criteria

I am not using medications that weaken my bones and prevent me from getting certain dental treatments.

I am under 12 years old.

Being unable or unwilling to consent to the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Placement of orthodontic miniscrews pretreated with K21 or ethanol for orthodontic therapy

8 weeks

Initial placement visit

Follow-up

Mobility and peri-implant inflammation assessed at follow-up appointments

8 weeks

2 visits (in-person) at 4 and 8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ethanol control
• K21 Cavity cleanser

Trial Overview 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.

How Is the Trial Designed?

Group I: K21 Cavity cleanser-coated TAD Experimental Treatment 1 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 Control Placebo Group 1 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.

Ethanol control is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ethanol for:

• Antiseptic
• Disinfectant

Approved in European Union as Ethanol for:

• Antiseptic
• Disinfectant
• Solvent

Approved in Canada as Ethanol for:

• Antiseptic
• Disinfectant

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

In a study involving 90 titanium disks and three different microbial strains, no single disinfectant technique was found to be the most effective against all types of biofilms associated with peri-implantitis, indicating variability in efficacy.

The study suggests that combining disinfectant techniques, such as photodynamic therapy with 3% hydrogen peroxide or 0.2% chlorhexidine, may enhance the overall effectiveness against these biofilms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of conventional and contemporary disinfectant techniques on three peri-implantitis associated microbiotas. Rismanchian, M., Nosouhian, S., Shahabouee, M., et al.[2018]

Local delivery agents (LDAs) like chlorhexidine and tetracycline can be effectively removed from dental implant surfaces with increased cleaning duration and pressure, while minocycline remains stubbornly attached due to its hydrophobic properties.

The persistence of LDA residues, especially minocycline, on implant surfaces could hinder reosseointegration and potentially serve as a reservoir for harmful microorganisms, suggesting that careful consideration is needed when using these agents in peri-implantitis treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of Local Delivery Agents for Treating Peri-Implantitis on Dental Implant Surfaces: A Preclinical Study. Lee, JB., Kweon, HH., Cho, HJ., et al.[2019]

Air-polishing with both erythritol/chlorhexidine and sodium bicarbonate effectively reduced bacterial biofilm viability on infected titanium disks, indicating their efficacy in managing infections around dental implants.

Erythritol/chlorhexidine not only removed existing biofilm but also significantly inhibited re-colonization after treatment, suggesting it may provide better long-term protection against infection compared to sodium bicarbonate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofilm Removal and Bacterial Re-Colonization Inhibition of a Novel Erythritol/Chlorhexidine Air-Polishing Powder on Titanium Disks. Mensi, M., Cochis, A., Sordillo, A., et al.[2020]

The study found that an amino-alcohol solution forms a stable and dense film on titanium dental implant surfaces, which may hinder proper healing and re-integration of the implant with surrounding tissues.

Ozone exposure effectively removes the adsorbed amino-alcohol from the titanium surface, suggesting a potential method to restore the implant surface for better healing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemical treatment of machined titanium surfaces. An in vitro study. Krozer, A., Hall, J., Ericsson, I.[2019]

In a study involving 20 patients and 40 implants, an antibacterial coating on implant-abutment junctions significantly reduced volatile organic compounds (VOCs) associated with microbial activity after 7 and 14 days compared to untreated implants.

The results suggest that the antibacterial coating can help maintain long-term peri-implant tissue health by preventing microbial activity within the implant internal chamber.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new antibacterial coating of the internal chamber of an implant via real time measurement of Volatile Organic Compounds (VOCs). Scarano, A., de Oliveira, PS., Leo, L., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10823988/

Effect of a novel quaternary ammonium silane based cavity ... 2% K21 QAS has the potential to be used as an effective cavity cleanser before the placement of RMGIC restorations.

2. withpower.com withpower.com/trial/k21-coating-for-miniscrew-stability-and-peri-implant-inflammation-f95a6

K21 Coating for Miniscrew Stability and Peri-implant ... Trial Overview The study is testing if K21 cavity cleanser coating on miniscrews can reduce inflammation and increase success rates compared to a standard ...

3. fitebacdental.com fitebacdental.com/product-line/fitebac-antimicrobial-cavity-cleanser/

FiteBac Antimicrobial Cavity Cleanser Data ... FiteBac® K21 QAS consists of 4 Silane Quaternary Ammonium structures covalently linked to a silane core. Studies have shown that K21 QAS demonstrates:.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37664740/

Antimicrobial FiteBac® K21 promotes ... K21 root canal irrigant was able to penetrate bacterial wall and can serve as a potential irrigant for therapeutic benefits.

5. fitebacdental.com fitebacdental.com/all-research/

All Research 26 - Effect of a novel quaternary ammonium silane based cavity cleanser FiteBa K21 QAS in comparison with other cavity disinfectants on the bond strength of ...

6. fitebacdental.com fitebacdental.com/k21qaspreliminaryfindings/

K21 QAS Drug Preliminary Findings K21 QAS Preliminary Findings ... FiteBac is a biotech company dedicated to making the world a safer place with our antimicrobial technology.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K200614.pdf

June 25, 2020 Largent Health, LLC Elizabeth O'keeffe Director ... The FiteBac® Antimicrobial Cavity Cleanser with 2% K21 QAS is an antimicrobial aqueous ethanolic solution intended for cleansing and ...