What side effects are associated with this type of intervention?

Common treatments for peri-implantitis using disinfectant gels such as hydrogen peroxide and chlorhexidine can have side effects including mucosal irritation and tissue damage (for hydrogen peroxide) and taste disturbances, tooth staining, and rare allergic reactions (for chlorhexidine). Combining these agents may enhance antimicrobial effects but also increase the risk of mucosal irritation.

What prior FDA approvals exist?

There are no specific FDA-approved drugs exclusively for the treatment of peri-implantitis. However, chlorhexidine, an antimicrobial agent, is commonly used in dental practice for managing peri-implantitis and other periodontal conditions. Chlorhexidine mouthwash (0.12%) has been studied for its efficacy in reducing peri-implant mucositis, although it was not found to be more effective than placebo. Hydrogen peroxide is another antimicrobial agent used in various dental applications, but specific FDA approval for peri-implantitis treatment is not documented. Overall, the use of these agents is based on their general antimicrobial properties rather than specific FDA approval for peri-implantitis.

What other types of research exist?

Promising novel alternatives to disinfectant gel for peri-implantitis treatment include the use of low-level laser therapy (LLLT), which has shown potential in improving healing and reducing symptoms related to peri-implantitis. Additionally, the application of autologous platelet concentrates (APC), also known as platelet-rich plasma, has been explored for its regenerative properties and ability to enhance healing in oral surgery contexts. Both methods aim to reduce bacterial load and promote a healthier microbiome, potentially improving implant success rates.

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Antiseptics for Dental Implant Success

Q: What is the mechanism of action of this treatment?

The most common treatments for peri-implantitis, such as the insertion of disinfectant gels like hydrogen peroxide and chlorhexidine, work primarily through their antimicrobial actions. Hydrogen peroxide releases oxygen, which helps to kill anaerobic bacteria by disrupting their cell walls. Chlorhexidine, on the other hand, binds to bacterial cell membranes, causing leakage of cell contents and ultimately bacterial death. These treatments are crucial for peri-implantitis patients as they reduce the bacterial load within the implant cavity, potentially shifting the microbiome towards less pathogenic species. This can improve implant success rates, reduce the need for surgical revisions, and lower associated healthcare costs.

Phase < 1

Recruiting

Research Sponsored by Madigan Army Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18-55 years old

Be between 18 and 65 years old

Must not have

Active periodontal disease

Medications that affect soft tissue or bone healing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up four months post dental implant insertion.

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include irritation at the application site within the mouth, altered taste sensation, tooth staining, and possibly a mild burning feeling when using either hydrogen peroxide or chlorhexidine gel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have active gum disease.

Select...

I am not taking medications that affect healing.

Select...

I have a condition that affects how my bones or soft tissues heal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ four months post dental implant insertion.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~four months post dental implant insertion.

This trial's timeline: 3 weeks for screening, Varies for treatment, and four months post dental implant insertion. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Implant Failure

Secondary study objectives

Bacterial Load

Microbiome Composition

Peri-Implantitis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chlorhexidine

2013

Completed Phase 4

~9050

Hydrogen Peroxide

2017

Completed Phase 3

~1640

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for peri-implantitis, such as the insertion of disinfectant gels like hydrogen peroxide and chlorhexidine, work primarily through their antimicrobial actions. Hydrogen peroxide releases oxygen, which helps to kill anaerobic bacteria by disrupting their cell walls. Chlorhexidine, on the other hand, binds to bacterial cell membranes, causing leakage of cell contents and ultimately bacterial death. These treatments are crucial for peri-implantitis patients as they reduce the bacterial load within the implant cavity, potentially shifting the microbiome towards less pathogenic species. This can improve implant success rates, reduce the need for surgical revisions, and lower associated healthcare costs.

The Effect of Different Implant Surfaces and Photodynamic Therapy on Periodontopathic Bacteria Using TaqMan PCR Assay following Peri-Implantitis Treatment in Dog Model.