Peri-ImplantitisEarly Phase 1NCT05024760
Antiseptic Effects on the Dental Implant Internal Surface Microbiome
A Early Phase 1 study testing Chlorhexidine and Hydrogen Peroxide in people with Peri-Implantitis and Peri-implant Mucositis, run by Madigan Army Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Peri-Implantitis, Peri-implant Mucositis, Implant Infection
- What is being tested?
- Chlorhexidine and Hydrogen Peroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2022to 1 May 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Active duty military
- 18-55 years old
- Over 6 months remaining at local duty station
Who cannot join
- Tobacco user
- Medications that affect soft tissue or bone healing
- Metabolic disorder that affects soft tissue or bone healing
- Active periodontal disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
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.
- Being tested
- Chlorhexidine, Hydrogen Peroxide
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineDrug
Chlorhexidine will be inserted into the dental implant internal cavity during dental implant insertion.
Hydrogen PeroxideDrug
Hydrogen Peroxide will be inserted into the internal cavity of the dental implant during dental implant insertion.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This arm will receive standard of care during dental implant insertion. |
| Chlorhexidine | Experimental | Chlorhexidine treatment. Receives: Drug: Chlorhexidine |
| Hydrogen Peroxide | Experimental | Hydrogen Peroxide treatment. Receives: Drug: Hydrogen Peroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Failure
We will compare the rates of dental implant failure between study arms.
Measured: Four months post dental implant insertion.
Secondary outcomes (3)
Peri-Implantitis
We will compare the rates of peri-implantitis between study arms.
Measured: Four months post dental implant insertion.
Bacterial Load
We will compare the bacterial load in the dental implant internal cavity between study arms.
Measured: Four months post dental implant insertion.
Microbiome Composition
We will compare the relative abundance of red and orange complex bacteria in the dental implant internal cavity between study arms.
Measured: Four months post dental implant insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start28 Jul 2022
- Primary completion31 Dec 2025
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is a 3 arm study with 1 arm receiving no treatment and 2 arms receiving treatments.
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madigan Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024760
- Sponsor's protocol ID
- Pending
- Status last verified
- Jul 2026
- First submitted
- 23 Aug 2021
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 19485117Atieh 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 23237585Podhorsky 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 27183065Schwarz 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 29926957Solderer 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 30535817Daubert 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 31407437Besimo 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 10531737Duarte 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 17076607Podhorsky 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 27611755Carinci 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 31405061D'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 20074465Ghannad 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 26411835Paolantonio 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 at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiseptic Effects on the Dental Implant Internal Surface Microbiome
- ClinicalTrials.gov ID
- NCT05024760
- Acronym / sponsor ID
- Pending
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Madigan Army Medical CenterUS federal agency
- Collaborators
- United States Department of Defense
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a 3 arm study with 1 arm receiving no treatment and 2 arms receiving treatments.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This arm will receive standard of care during dental implant insertion. |
| Chlorhexidine | Experimental | Drug: ChlorhexidineChlorhexidine treatment. |
| Hydrogen Peroxide | Experimental | Drug: Hydrogen PeroxideHydrogen Peroxide treatment. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Active duty military
- 18-55 years old
- Over 6 months remaining at local duty station
Key exclusion criteria (4 listed)
- Tobacco user
- Medications that affect soft tissue or bone healing
- Metabolic disorder that affects soft tissue or bone healing
- Active periodontal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChlorhexidineChlorhexidine will be inserted into the dental implant internal cavity during dental implant insertion. | Drug | Chlorhexidine |
| Hydrogen PeroxideHydrogen Peroxide will be inserted into the internal cavity of the dental implant during dental implant insertion. | Drug | Hydrogen Peroxide |
Primary outcome
Implant Failure
Time frame: Four months post dental implant insertion.
We will compare the rates of dental implant failure between study arms.
3 secondary outcomes
Peri-Implantitis
Time frame: Four months post dental implant insertion.
Bacterial Load
Time frame: Four months post dental implant insertion.
Microbiome Composition
Time frame: Four months post dental implant insertion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 19485117Battle-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.
- Background: PubMed 23237585Atieh 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.
- Background: PubMed 27183065Podhorsky 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.
- Background: PubMed 29926957Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350.
- Background: PubMed 30535817Solderer 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.
- Background: PubMed 31407437Daubert DM, Weinstein BF. Biofilm as a risk factor in implant treatment. Periodontol 2000. 2019 Oct;81(1):29-40. doi: 10.1111/prd.12280.
- Background: PubMed 10531737Besimo 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.
- Background: PubMed 17076607Duarte 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.
- Background: PubMed 27611755Podhorsky 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.
- Background: PubMed 31405061Carinci 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.
- Background: PubMed 20074465D'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.
- Background: PubMed 26411835Ghannad 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Chlorhexidine and Hydrogen Peroxide in people with Peri-Implantitis and Peri-implant Mucositis, run by Madigan Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Failure (time frame: Four months post dental implant insertion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05024760, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.