Antiseptics for Dental Implant Success

Overseen By Zachary T Colburn, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Madigan Army Medical Center

Must not be taking: Bone healing drugs

Disqualifiers: Tobacco use, Metabolic disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 months

150 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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. ^{2 3 6 8 9}

Are You a Good Fit for This Trial?

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

Exclusion Criteria

I have active gum disease.

Tobacco user

I am not taking medications that affect healing.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Chlorhexidine
• Hydrogen Peroxide

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

In a study involving 30 patients with peri-implant mucositis, both chlorhexidine 0.2% mouthwash and 1% gel were found to be equally effective in reducing inflammation and improving probing depth over time.

Patients preferred the gel formulation for its effectiveness, despite finding it more challenging to use, indicating that both formulations are beneficial adjuncts to mechanical therapy for this condition.

NCBI (Pubmed)

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. De Siena, F., Francetti, L., Corbella, S., et al.[2013]

Adjunctive use of chlorhexidine (CHX) significantly reduced probing depths in patients with peri-implant mucositis compared to controls, indicating some efficacy in this condition based on a meta-analysis of 14 studies.

However, CHX did not show a significant effect on bleeding during probing in peri-implant mucositis, and its impact on peri-implantitis remains unclear due to limited data, suggesting that its overall effectiveness in treating these conditions is still uncertain.

NCBI (Pubmed)

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. Ye, M., Liu, W., Cheng, S., et al.[2023]

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]

Hypochlorous acid (HOCl) demonstrated superior antibacterial efficacy against both Gram-negative and Gram-positive bacteria on biofilm-contaminated titanium alloy surfaces, especially with increased irrigating volumes and longer exposure times.

HOCl not only effectively killed bacteria but also significantly reduced the concentration of lipopolysaccharides from P. gingivalis, suggesting it may be a highly effective antiseptic for cleaning dental implants affected by peri-implantitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Hypochlorous Acid to Reduce the Biofilms on Titanium Alloy Surfaces in Vitro. Chen, CJ., Chen, CC., Ding, SJ.[2022]

In a study involving 46 patients with peri-implant mucositis, the use of a mouthwash containing 0.20% chlorhexidine and hyaluronic acid led to significantly better clinical outcomes compared to other treatments after 6 months.

Patients using the chlorhexidine and hyaluronic acid mouthwash showed a greater reduction in harmful bacteria associated with gum disease, indicating its effectiveness in improving oral health around dental implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study examining the effects of chlorhexidine (CHX)-based mouthwashes on osteoblast-like cells, 0.2% CHX was found to have the highest cytotoxicity, suggesting potential risks for bone healing during peri-implantitis treatment.

All tested CHX mouthwashes induced lower levels of apoptosis compared to the control, but the significant cytotoxic effects of 0.2% CHX indicate that its use in surgical settings should be approached with caution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Three Chlorhexidine-Based Mouthwashes on Human Osteoblast-Like SaOS-2 Cells. An In Vitro Study. Brunello, G., Becker, K., Scotti, L., et al.[2021]

In a study involving 822 patients at risk for alveolar osteitis (AO) after tooth extraction, chlorhexidine 0.12% mouthwash significantly reduced the incidence of AO by 63%, with only 2.69% of patients developing AO compared to 7.26% in the placebo group.

The study found no adverse effects associated with chlorhexidine use, confirming its safety and efficacy for preventing AO in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chlorhexidine for prevention of alveolar osteitis: a randomised clinical trial. Halabi, D., Escobar, J., Alvarado, C., et al.[2018]

In a study involving 44 patients with peri-implantitis, the use of a 2% chlorhexidine (CHX) solution for implant surface decontamination did not show any significant clinical or radiographic advantages compared to a 0.12% CHX + 0.05% cetylpyridinium chloride (CPC) solution over a 12-month follow-up period.

Both decontamination methods effectively reduced anaerobic bacterial counts on the implant surface, but neither method led to improved clinical outcomes, indicating that while chemical decontamination is beneficial, it does not enhance the overall treatment effectiveness for peri-implantitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implant decontamination with 2% chlorhexidine during surgical peri-implantitis treatment: a randomized, double-blind, controlled trial. de Waal, YC., Raghoebar, GM., Meijer, HJ., et al.[2017]

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]

Citations

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]