Actively Recruiting

Early Phase 1
Age: 18Years - 55Years
All Genders
ID05024760

Antiseptic Effects on the Dental Implant Internal Surface Microbiome to Reduce Implant Failure in Active Duty Military

Led by Madigan Army Medical Center · Updated on 2024-12-27

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Madigan Army Medical Center

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to study the effects of disinfectant gels on the bacteria inside dental implants, focusing on military personnel who face higher risks of oral injuries that can affect their dental health and readiness. The study evaluates how hydrogen peroxide or chlorhexidine gels inserted into the internal cavity of dental implants may influence implant failure rates, bacterial load, and the types of bacteria present. These infections, such as peri-implant mucositis and peri-implantitis, cause bone loss and inflammation around implants and are common issues that can affect implant success. Participants will be randomly assigned to one of three groups: a control group receiving standard care, a group receiving chlorhexidine gel, or a group receiving hydrogen peroxide gel applied inside the dental implant cavity during implant insertion. The study focuses on early-phase research to assess how these antiseptic treatments impact bacterial presence and implant outcomes over a four-month period after the implant procedure. During the study, participants will be monitored for implant failure, the development of peri-implantitis, bacterial amounts, and changes in the bacterial community at four months post-implant insertion. Researchers will collect data through clinical assessments and microbiome analysis to understand how these treatments affect infection and implant health. The total participation duration includes the initial implant procedure and follow-up evaluations within four months, with the goal of improving dental implant success and military readiness.

CONDITIONS

Brief Title

Antiseptic Effects on the Dental Implant Internal Surface Microbiome

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Active duty military
  • Age between 18 and 55 years
  • At least 6 months remaining at local duty station
Not Eligible

You will not qualify if you...

  • Tobacco user
  • Taking medications that affect soft tissue or bone healing
  • Having metabolic disorders that affect soft tissue or bone healing
  • Active periodontal disease present

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 4 months post dental implant insertion

Participants receive dental implant insertion with either standard care, chlorhexidine, or hydrogen peroxide placed inside the implant's internal cavity to reduce bacterial load and improve implant success.

1 visit for implant insertion and follow-up visits as scheduled up to 4 months

Trial Site Locations

Total: 1 location

1

Madigan Army Medical Center

Tacoma, Washington, United States, 98431

Actively Recruiting

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Research Team

K

Kevin D Smith, DMD

Z

Zachary T Colburn, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Retrospective analysis of dental implants among United States Air Force basic military trainees.

Shelrethia O Battle-Siatita, Joseph A Bartoloni, Raymond H Hancock...

https://pubmed.ncbi.nlm.nih.gov/19485117

Transfer of Bacteria into the Internal Cavity of Dental Implants After Application of Disinfectant or Sealant Agents In Vitro.

Anke Podhorsky, Stefanie Biscoping, Peter Rehmann...

https://pubmed.ncbi.nlm.nih.gov/27183065

Bacterial Contamination of the Internal Cavity of Dental Implants After Application of Disinfectant or Sealant Agents Under Cyclic Loading In Vitro.

Anke Podhorsky, Sven Putzier, Peter Rehmann...

https://pubmed.ncbi.nlm.nih.gov/27611755