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

Trial Summary

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 makes the K21 Cavity cleanser treatment unique for miniscrew stability and peri-implant inflammation?

The K21 Cavity cleanser, which includes ethanol, is unique because it forms a stable and dense film on implant surfaces, potentially preventing microbial growth and inflammation around dental implants, unlike other treatments that may not provide such a protective coating. ^{1 2 3 4 5}

What is the purpose of this trial?

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Biofilm Removal and Bacterial Re-Colonization Inhibition of a Novel Erythritol/Chlorhexidine Air-Polishing Powder on Titanium Disks. [2020]

2. Denmark pubmed.ncbi.nlm.nih.gov

Chemical treatment of machined titanium surfaces. An in vitro study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of conventional and contemporary disinfectant techniques on three peri-implantitis associated microbiotas. [2018]

4. Singapore 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). [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Characteristics of Local Delivery Agents for Treating Peri-Implantitis on Dental Implant Surfaces: A Preclinical Study. [2019]