Antiseptic Effects on the Dental Implant Internal Surface Microbiome

Part of paid clinical trials in Tacoma, Washington.

Sponsor
Madigan Army Medical Center
Study ID
NCT05024760
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Chlorhexidine — DRUG
    Chlorhexidine will be inserted into the dental implant internal cavity during dental implant insertion.
  • Hydrogen Peroxide — DRUG
    Hydrogen Peroxide will be inserted into the internal cavity of the dental implant during dental implant insertion.

Study Details

Soldiers operate in environments that are more likely to lead to oral trauma, risking poor dentition which can directly impact military readiness. Dental restoration can often be accomplished via dental implant insertion. Microbiome-associated complications that result in bone loss, including the micro-leakage of bacterial species proliferating in the dental implant internal cavity, frequently lead to implant failure. Reduction in implant bacterial load may result in a shift of the composition of the microbiome in favor of less pathogenic species, potentially improving dental implant success rates, reducing surgical revisions, and associated cost savings. This study aims to determine how disinfectant gel (hydrogen peroxide or chlorhexidine) insertion into dental implant internal cavities affects implant failure rates, bacterial load and microbiome composition.

Key Dates

Start date
Jul 28, 2022
Status verified
Dec 2024
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • No Intervention: Control
    This arm will receive standard of care during dental implant insertion.
  • Experimental: Chlorhexidine
    Chlorhexidine treatment.
  • Experimental: Hydrogen Peroxide
    Hydrogen Peroxide treatment.

Primary Outcome Measure

Implant Failure [ Time Frame: Four months post dental implant insertion. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Madigan Army Medical CenterTacomaWashington98431
Kevin Smith
[email protected]
253-968-0181

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Madigan Army Medical Center· Tacoma, WA

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