Antiseptics for Dental Implant Success

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Madigan Army Medical Center

Must not be taking: Bone healing drugs

Disqualifiers: Tobacco use, Metabolic disorders, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests special cleaning gels inside dental implants to help soldiers avoid infections and improve implant success. The gels work by reducing harmful bacteria that can cause bone loss and swelling. Chlorhexidine (CHX) is a commonly used medicine that helps reduce bacteria and swelling during dental procedures.

Will I have to stop taking my current medications?

The trial excludes participants who are on medications that affect soft tissue or bone healing, so you may need to stop taking such medications to participate.

What data supports the effectiveness of the treatment Chlorhexidine for dental implant success?

Research shows that chlorhexidine, when used as an additional treatment, can help manage infections around dental implants by reducing bacteria and inflammation. Studies have found it effective in treating conditions like peri-implant mucositis, which is inflammation around the implant. ^{1 2 3 4 5}

Is chlorhexidine safe for use in dental treatments?

Chlorhexidine is generally safe for use in dental treatments, as shown in a study where 0.12% chlorhexidine mouthwash was used after tooth extraction without any reported adverse effects. However, higher concentrations like 0.2% chlorhexidine may have a higher cytotoxic effect on cells, so its use should be carefully considered. ^{2 3 6 7 8}

How does the antiseptic treatment for dental implant success differ from other treatments?

This treatment is unique because it uses chlorhexidine (CHX), a broad-spectrum antimicrobial agent, which can be applied directly to the implant site to reduce bacterial load and inflammation, potentially improving implant success. Unlike other treatments, it focuses on the direct application of CHX to the implant surface, which may enhance its effectiveness in reducing peri-implant infections. ^{1 2 3 5 9}

Research Team

Eligibility Criteria

This trial is for active duty military personnel aged 18-55 with over 6 months remaining at their local station. It's not for tobacco users, those with metabolic disorders affecting healing, active gum disease, or anyone on medication that impacts tissue or bone recovery.

Inclusion Criteria

Active duty military

Over 6 months remaining at local duty station

I am between 18 and 55 years old.

Exclusion Criteria

I have active gum disease.

Tobacco user

I am not taking medications that affect healing.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either hydrogen peroxide or chlorhexidine treatment in the dental implant internal cavity

4 months

Regular visits for treatment application and monitoring

Follow-up

Participants are monitored for implant failure, peri-implantitis, bacterial load, and microbiome composition

4 months

Follow-up visits to assess outcomes

Treatment Details

Interventions

• Chlorhexidine (Antiseptic)
• Hydrogen Peroxide (Antiseptic)

Trial Overview The study tests if disinfectant gels (hydrogen peroxide or chlorhexidine) can reduce bacterial load and change the microbiome in dental implants to prevent failure. Participants will receive one of these antiseptics directly into the implant cavity.

Participant Groups

Group I: Hydrogen Peroxide Experimental Treatment 1 Intervention

Hydrogen Peroxide treatment.

Group II: Chlorhexidine Experimental Treatment 1 Intervention

Chlorhexidine treatment.

Group III: Control Active Control 1 Intervention

This arm will receive standard of care during dental implant insertion.

Who Is Running the Clinical Trial?

Madigan Army Medical Center

Lead Sponsor

Trials

52

Recruited

17,600+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Pete Hegseth

United States Department of Defense

Chief Executive Officer

Bachelor's degree in Political Science from Princeton University, JD from Harvard Law School

Lisa Hershman

United States Department of Defense

Chief Medical Officer since 2021

MD from Uniformed Services University of the Health Sciences

Findings from Research

Modified titanium surfaces, specifically sandblasted and acid-etched (SLA) and resorbable blast media (RBM), can effectively release chlorhexidine (CHX) after exposure, showing higher release rates compared to untreated surfaces.

The study found that these modified surfaces not only released CHX but also demonstrated significant antimicrobial activity against Streptococcus gordonii, indicating their potential effectiveness in treating peri-implant infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chlorhexidine Uptake and Release From Modified Titanium Surfaces and Its Antimicrobial Activity. Ryu, HS., Kim, YI., Lim, BS., et al.[2018]

In a study involving 40 patients, the application of 1% chlorhexidine gel during dental implant procedures significantly reduced gingival inflammation, as indicated by lower gingival index scores at both 1 week and 3 months compared to the control group.

The use of chlorhexidine gel also correlated with lower levels of interleukin 1-β, a marker of inflammation, suggesting that this treatment may help manage peri-implant soft tissue health effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single application of chlorhexidine gel reduces gingival inflammation and interleukin 1-β following one-stage implant placement: A randomized controlled study. Asbi, T., Hussein, HA., Horwitz, J., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Topical application of 1% chlorhexidine gel versus 0.2% mouthwash in the treatment of peri-implant mucositis. An observational study. [2013]

2. Pakistan pubmed.ncbi.nlm.nih.gov

Efficacy of Adjunctive Chlorhexidine in non-surgical treatment of Peri-Implantitis/Peri-Implant Mucositis: An updated systematic review and meta-analysis. [2023]

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

Chlorhexidine Uptake and Release From Modified Titanium Surfaces and Its Antimicrobial Activity. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Hypochlorous Acid to Reduce the Biofilms on Titanium Alloy Surfaces in Vitro. [2022]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Clinical and microbiological evaluation of hyaluronic acid and chlorhexidine mouthwash in the treatment of peri-implant mucositis]. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of Three Chlorhexidine-Based Mouthwashes on Human Osteoblast-Like SaOS-2 Cells. An In Vitro Study. [2021]

7. Brazil pubmed.ncbi.nlm.nih.gov

Chlorhexidine for prevention of alveolar osteitis: a randomised clinical trial. [2018]

8. Denmark pubmed.ncbi.nlm.nih.gov

Implant decontamination with 2% chlorhexidine during surgical peri-implantitis treatment: a randomized, double-blind, controlled trial. [2017]

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

A single application of chlorhexidine gel reduces gingival inflammation and interleukin 1-β following one-stage implant placement: A randomized controlled study. [2021]