150 Participants Needed

Antiseptics for Dental Implant Success

KD
ZT
Overseen ByZachary T Colburn, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: Madigan Army Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.12345

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.23678

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.12359

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.

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

Exclusion Criteria

I have active gum disease.
Tobacco user
I am not taking medications that affect healing.
See 1 more

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
  • 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.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Hydrogen PeroxideExperimental Treatment1 Intervention
Hydrogen Peroxide treatment.
Group II: ChlorhexidineExperimental Treatment1 Intervention
Chlorhexidine treatment.
Group III: ControlActive Control1 Intervention
This arm will receive standard of care during dental implant insertion.

Find a Clinic Near You

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+

Findings from Research

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

References

Topical application of 1% chlorhexidine gel versus 0.2% mouthwash in the treatment of peri-implant mucositis. An observational study. [2013]
Efficacy of Adjunctive Chlorhexidine in non-surgical treatment of Peri-Implantitis/Peri-Implant Mucositis: An updated systematic review and meta-analysis. [2023]
Chlorhexidine Uptake and Release From Modified Titanium Surfaces and Its Antimicrobial Activity. [2018]
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]
The Effects of Three Chlorhexidine-Based Mouthwashes on Human Osteoblast-Like SaOS-2 Cells. An In Vitro Study. [2021]
Chlorhexidine for prevention of alveolar osteitis: a randomised clinical trial. [2018]
Implant decontamination with 2% chlorhexidine during surgical peri-implantitis treatment: a randomized, double-blind, controlled trial. [2017]
A single application of chlorhexidine gel reduces gingival inflammation and interleukin 1-β following one-stage implant placement: A randomized controlled study. [2021]
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