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CompletedNCT05024760Updated Jul 22, 2026

Antiseptic Effects on the Dental Implant Internal Surface Microbiome

An Early Phase 1 interventional study of Chlorhexidine and Hydrogen Peroxide in Peri-Implantitis, Peri-implant Mucositis and Implant Infection, sponsored by Madigan Army Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Madigan Army Medical Center · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
97
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
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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.

Read the detailed description

Clinical Background

Peri-implantitis/mucositis is bone loss/tissue inflammation around a dental implant. This is caused by bacterial biofilm at the interface between the implant and bone/tissue. The source of bacteria comes from the internal surface of the implant, and leaks through the implant/abutment interface. After the dental implant is placed in bone, bacteria from the saliva and blood within the internal surface of the implant leak out. The body reacts to this bacterial exposure with inflammation, resulting in bone loss around the implant/abutment interface.

Warfighters are exposed to situations in which the risk of dental trauma is elevated compared with the civilian population. This is particularly problematic for the military because poor dentition can disqualify Soldiers from service. Proper mastication is crucial to readiness. The number of implants inserted annually has risen by more than 10-fold since the 1980s. There are now over 700,000 implants inserted annually (Battle-Siatita et al., 2009). Unfortunately, implant-associated infections such as peri-implant mucositis and peri-implantitis are common, affecting approximately 63% and 19% of recipients, respectively (Atieh et al., 2013). Though, it should be noted that others have suggested the number could be as high as 80% (Podhorsky et al., 2016). Because these conditions negatively impact implant success rates, preventive measures aimed at reducing the risk of these diseases have tremendous potential to transform dental care and improve readiness.

Previous studies have found evidence suggesting that microbial profiles differ between healthy implants and those exhibiting peri-implantitis (Schwarz et al., 2018). For example, at least 19 species such as Porphyromonas gingivalis, Pseudomonas aeruginosa, and Staphylococcus aureus are more abundant on affected implants (Schwarz et al., 2018). Thus, it may be important to not only control total bacterial load but also to ensure that any intervention produces a favorable change in the implant-associated microbial profile.

A recent systematic review determined that there is strong evidence to support the use of chlorhexidine rinses after implant surgery (Solderer et al., 2019). The positive effects of chlorhexidine rinses on implant success appear to be the result of the impact of chlorhexidine on reducing biofilm-related complications (Daubert \& Weinstein, 2019; Solderer et al., 2019). While the effects of chlorhexidine rinses have been well described, there has been little investigation into the potential impact of disinfectants placed within the internal cavity of dental implants. A PubMed search for "dental implant internal disinfectant" returned only 15 articles in English. Of the articles considering the implant's internal cavity, 4 were in vitro studies (Besimo et al., 1999; Duarte et al., 2006; Podhorsky, Biscoping, et al., 2016; Podhorsky, Putzier, et al., 2016). All 4 studies strongly support the use of chlorhexidine gel in the internal cavity of implants. Another 4 studies, examined the ability of chlorhexidine gel placed within the dental implant internal cavity to affect total bacterial load between 3 and 6 months after surgery (Carinci et al., 2019; D'Ercole et al., 2009; Ghannad et al., 2015; Paolantonio et al., 2008). All 4 studies reported that intervention resulted in decreased bacterial load. Using PCR specific to only 6 bacterial taxa or using culturing methods, two of these manuscripts reported no change in microbial profiles (Ghannad et al., 2015; Paolantonio et al., 2008). However, one paper reported that the gel altered microbial profiles (D'Ercole et al., 2009). Given that the oral microbiome consists of hundreds of bacterial species, these previous studies have inadequately examined the impact of chlorhexidine gel on microbial profiles. Moreover, there have been no studies examining the use of alternative disinfectants. Another common disinfectant used intraorally is hydrogen peroxide. This disinfectant is used to treat periodontitis and for teeth whitening. We propose to analyze the effect of this second material on total bacterial load and the microbial profile within the internal aspect of the dental implant.

The rate and degree of peri-implantitis/mucositis, bone/tissue loss, and inflammation, coupled with the determination of bacterial load and microbiome composition will allow for the determination of the value of hydrogen peroxide or chlorhexidine placed within the dental implant internal cavity.

Problem/Question

Certain bacteria from the saliva and blood that get inside the implant are more pathogenic (disease causing) than others. In the dental field, there are topcial agents regularly used as mouth rinses to decrease this bacterial load, and create a healthier bacterial environment with less pathogenic potential.

Because of the nature of the job, warfighters are at increased risk of oral trauma compared with the civilian population. Corrective procedures following trauma often include the insertion of dental implants. The number of annual dental implant insertions has risen more than 10-fold since the 1980s, and now sits at more than 700,000 per year (Battle-Siatita et al., 2009). Unfortunately, dental implant failure rates are high. This has high costs because of the need for additional surgeries, reduced quality of care, and reduced warfighter readiness. The implant-associated microbiome has been implicated as a key effector in implant failure and bone loss. In this study, we aim to evaluate methods that reduce or alter the implant-associated microbiome and therefore improve implant success rates.

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Conditions studied

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

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03

In context

Peri-Implantitis

322 studies on the registry are indexed under Peri-Implantitis; 88 are open to participants now.

This study's enrollment of 97 is above the median of 40 across 195 interventional studies indexed under Peri-Implantitis.

Browse Peri-Implantitis studies →

Lead sponsor

Madigan Army Medical Center is the lead sponsor of 26 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Active duty military
  • 18-55 years old
  • Over 6 months remaining at local duty station

Exclusion criteria

Exclusion Criteria:

  • Tobacco user
  • Medications that affect soft tissue or bone healing
  • Metabolic disorder that affects soft tissue or bone healing
  • Active periodontal disease
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
97 participants (actual)

Study arms

  • No intervention
    Control

    This arm will receive standard of care during dental implant insertion.

  • Experimental
    Chlorhexidine

    Chlorhexidine treatment.

    Drug: Chlorhexidine

  • Experimental
    Hydrogen Peroxide

    Hydrogen Peroxide treatment.

    Drug: Hydrogen Peroxide

Interventions

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

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

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What researchers measure

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.

07

Study locations

1 site
  • Madigan Army Medical Center
    Tacoma, Washington 98431, United States
08

References and documents

Publications

  • Battle-Siatita SO, Bartoloni JA, Hancock RH, Chong CH. Retrospective analysis of dental implants among United States Air Force basic military trainees. Mil Med. 2009 Apr;174(4):437-40. doi: 10.7205/milmed-d-02-5008. PubMed 19485117 ↗
  • Atieh MA, Alsabeeha NH, Faggion CM Jr, Duncan WJ. The frequency of peri-implant diseases: a systematic review and meta-analysis. J Periodontol. 2013 Nov;84(11):1586-98. doi: 10.1902/jop.2012.120592. Epub 2012 Dec 13. PubMed 23237585 ↗
  • Podhorsky A, Biscoping S, Rehmann P, Streckbein P, Domann E, Wostmann B. Transfer of Bacteria into the Internal Cavity of Dental Implants After Application of Disinfectant or Sealant Agents In Vitro. Int J Oral Maxillofac Implants. 2016 May-Jun;31(3):563-70. doi: 10.11607/jomi.4408. PubMed 27183065 ↗
  • Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350. PubMed 29926957 ↗
  • Solderer A, Kaufmann M, Hofer D, Wiedemeier D, Attin T, Schmidlin PR. Efficacy of chlorhexidine rinses after periodontal or implant surgery: a systematic review. Clin Oral Investig. 2019 Jan;23(1):21-32. doi: 10.1007/s00784-018-2761-y. Epub 2018 Dec 7. PubMed 30535817 ↗
  • Daubert DM, Weinstein BF. Biofilm as a risk factor in implant treatment. Periodontol 2000. 2019 Oct;81(1):29-40. doi: 10.1111/prd.12280. PubMed 31407437 ↗
  • Besimo CE, Guindy JS, Lewetag D, Meyer J. Prevention of bacterial leakage into and from prefabricated screw-retained crowns on implants in vitro. Int J Oral Maxillofac Implants. 1999 Sep-Oct;14(5):654-60. PubMed 10531737 ↗
  • Duarte AR, Rossetti PH, Rossetti LM, Torres SA, Bonachela WC. In vitro sealing ability of two materials at five different implant-abutment surfaces. J Periodontol. 2006 Nov;77(11):1828-32. doi: 10.1902/jop.2006.060101. PubMed 17076607 ↗
  • Podhorsky A, Putzier S, Rehmann P, Streckbein P, Domann E, Wostmann B. Bacterial Contamination of the Internal Cavity of Dental Implants After Application of Disinfectant or Sealant Agents Under Cyclic Loading In Vitro. Int J Prosthodont. 2016 Sep-Oct;29(5):493-5. doi: 10.11607/ijp.4546. PubMed 27611755 ↗
  • Carinci F, Lauritano D, Bignozzi CA, Pazzi D, Candotto V, Santos de Oliveira P, Scarano A. A New Strategy Against Peri-Implantitis: Antibacterial Internal Coating. Int J Mol Sci. 2019 Aug 9;20(16):3897. doi: 10.3390/ijms20163897. PubMed 31405061 ↗
  • D'Ercole S, Tete S, Catamo G, Sammartino G, Femminella B, Tripodi D, Spoto G, Paolantonio M. Microbiological and biochemical effectiveness of an antiseptic gel on the bacterial contamination of the inner space of dental implants: a 3-month human longitudinal study. Int J Immunopathol Pharmacol. 2009 Oct-Dec;22(4):1019-26. doi: 10.1177/039463200902200417. PubMed 20074465 ↗
  • Ghannad F, Alkadi LT, Wiebe CB, Shen Y, Haapasalo M, Larjava HS. Intra-operative application of chlorhexidine gel reduces bacterial counts in internal implant cavity. Eur J Oral Sci. 2015 Dec;123(6):425-31. doi: 10.1111/eos.12213. Epub 2015 Sep 28. PubMed 26411835 ↗
  • Paolantonio M, Perinetti G, D'Ercole S, Graziani F, Catamo G, Sammartino G, Piccolomini R. Internal decontamination of dental implants: an in vivo randomized microbiologic 6-month trial on the effects of a chlorhexidine gel. J Periodontol. 2008 Aug;79(8):1419-25. doi: 10.1902/jop.2008.070660. PubMed 18672991 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2022 to primary completion in Dec 2025, 41 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2021
First posted
Aug 27, 2021
StartActual
Jul 28, 2022
Primary completionActual
Dec 31, 2025
CompletionActual
May 1, 2026
Last update
Jul 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05024760
Lead sponsor
Madigan Army Medical Center
Collaborators
United States Department of Defense
Responsible party
Sponsor
First posted
Aug 27, 2021
Start date
Jul 28, 2022
Primary completion
Dec 31, 2025
Completion
May 1, 2026
Last update
Jul 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Chlorhexidine · Hydrogen Peroxide

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