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Antiseptic Effects on the Dental Implant Internal Surface Microbiome

NCT05024760 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-12-27

No results posted yet for this study

Summary

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.

Conditions

  • Peri-Implantitis
  • Peri-implant Mucositis
  • Implant Infection
  • Dental Implant Failed

Interventions

DRUG

Chlorhexidine

Chlorhexidine will be inserted into the dental implant internal cavity during dental implant insertion.

DRUG

Hydrogen Peroxide

Hydrogen Peroxide will be inserted into the internal cavity of the dental implant during dental implant insertion.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Madigan Army Medical Center

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-28
Primary Completion
2025-11-30
Completion
2025-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05024760 on ClinicalTrials.gov