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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether two antiseptic gels, hydrogen peroxide and chlorhexidine, can prevent dental implant failure by reducing harmful oral bacteria. It specifically examines if these treatments can improve implant success rates and reduce the need for additional surgeries. The trial suits active duty military members with at least six months remaining at their current duty station, who do not use tobacco and do not have certain health conditions affecting healing. As an Early Phase 1 trial, this research aims to understand how these treatments work in people, offering participants a chance to contribute to groundbreaking dental health advancements.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that chlorhexidine is generally safe for dental use. One study found no harmful effects when used to prevent mouth infections in high-risk patients, suggesting it is well-tolerated for dental implant procedures.

For hydrogen peroxide, research indicates it can effectively clean dental implants. One study found that hydrogen peroxide disinfects implants as well as, or better than, chlorhexidine. However, detailed safety information for hydrogen peroxide is limited. Another study on hydrogen peroxide mouthwash showed it to be safe, but this was for a different purpose.

Both treatments are under study to determine if they reduce bacteria and improve the success of dental implants.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about using antiseptics like Chlorhexidine and Hydrogen Peroxide for dental implant success because they offer potential benefits beyond the standard of care, which typically involves basic oral hygiene practices. Chlorhexidine is known for its strong antibacterial properties, helping to reduce the risk of infection after implant surgery. Hydrogen Peroxide, on the other hand, not only kills bacteria but also has a bubbling action that can help clean and remove debris around the implant site. These unique features could potentially improve healing and implant success rates, providing a promising complement to existing dental care routines.

What evidence suggests that this trial's treatments could be effective for improving dental implant success rates?

Research has shown that chlorhexidine, which participants in this trial may receive, helps manage infections around dental implants by reducing bacteria and swelling. This leads to fewer problems with the gums and bone around the implant, potentially improving implant success. Another treatment option in this trial is hydrogen peroxide, which has demonstrated equal or even better results in cleaning dental implants compared to chlorhexidine, especially when combined with a laser. Both treatments aim to clean the implant area to prevent harmful bacteria from causing issues. These findings suggest that using either chlorhexidine or hydrogen peroxide could improve dental implant success rates by maintaining a cleaner and healthier area.12467

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.
See 1 more

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?
3Treatment groups
Experimental Treatment
Active Control
Group I: Hydrogen PeroxideExperimental Treatment1 Intervention
Group II: ChlorhexidineExperimental Treatment1 Intervention
Group III: ControlActive Control1 Intervention

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+

Published Research Related to This Trial

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

Citations

The Effectiveness of the Association of Chlorhexidine with ...The association of chlorhexidine with the mechanical treatment of peri-implant mucositis has a role in reducing inflammation.
Antiseptic Effects on the Dental Implant Internal Surface ...This study aims to determine how disinfectant gel (hydrogen peroxide or chlorhexidine) insertion into dental implant internal cavities affects implant failure ...
Effect of preoperative chlorhexidine, essential oil, and ...Preoperative chlorhexidine, essential oil, and cetylpyridinium chloride mouthwashes can reduce the bacterial load at the time of implant placement.
Antiseptics for Dental Implant SuccessResearch shows that chlorhexidine, when used as an additional treatment, can help manage infections around dental implants by reducing bacteria and inflammation ...
The efficacy of implant surface decontamination using ...The local use of chlorhexidine had no overall effect on treatment outcomes. The effect of adjunctive systemic antibiotics depended on implant ...
Chlorhexidine in Dentistry: Pharmacology, Uses, and ...The aim of this work was to review the current uses of chlorhexidine (CHX) in dentistry based on its mechanism of action, ...
Operative Infection Rate of Dental Implants- A Systematic ...Since its first introduction, the usage of chlorhexidine has increased. The same holds for dental implants. Implant failures can happen, even.
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