Antiseptic Effects on the Dental Implant Internal Surface Microbiome

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMadigan Army Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Active duty military

18-55 years old

Over 6 months remaining at local duty station

Disqualifiers

Tobacco user

Medications that affect soft tissue or bone healing

Metabolic disorder that affects soft tissue or bone healing

Active periodontal disease

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: ChlorhexidineExperimental treatment 1 intervention
Group C: Hydrogen PeroxideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Implant Failure

We will compare the rates of dental implant failure between study arms.

Time frame
Four months post dental implant insertion.

Secondary outcomes

1

Peri-Implantitis

We will compare the rates of peri-implantitis between study arms.

Time frame
Four months post dental implant insertion.
2

Bacterial Load

We will compare the bacterial load in the dental implant internal cavity between study arms.

Time frame
Four months post dental implant insertion.
3

Microbiome Composition

We will compare the relative abundance of red and orange complex bacteria in the dental implant internal cavity between study arms.

Time frame
Four months post dental implant insertion.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Madigan Army Medical Center

Lead sponsor

United States Department of Defense

Collaborator