Periodontitis Stage IVPhase 1NCT07792902
Microbiological Modulation Of The Oral-Gut Axis After Treatment With Or Without Systemic Use Of Probiotics In Patients With Periodontitis: A Randomized Controlled Clinical Study.
A Phase 1 study testing Probiotics Bifidobacterium animalis subsp. lactis HN019 in people with Periodontitis Stage IV and Periodontitis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study aims to evaluate whether the oral administration of probiotics, in combination with conventional periodontal treatment (deep cleaning of the tooth root surfaces), can improve oral health and influence the relationship between oral and gut bacteria in individuals with periodontitis. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis Stage IV, Periodontitis
- What is being tested?
- Probiotics Bifidobacterium animalis subsp. lactis HN019
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Jun 2026to 15 Jul 2026
- Phase
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemically healthy individuals;
- Age of 30 years or older;
- Both genders;
- At least 15 teeth, excluding third molars and teeth indicated for extraction
- At least 30% of the teeth presenting probing depth (PD) and clinical attachment loss (CAL) greater than or equal to 5 mm;
- Individuals diagnosed with generalized Stage III or IV, Grade B or C periodontitis;
- Presence of at least 8 teeth with at least one non-contiguous interproximal site presenting probing depth (PD) and clinical attachment level (CAL) greater than or equal to 5 mm.
Who cannot join
- Current smokers or former smokers who quit within the past 5 years;
- Pregnant or breastfeeding women;
- History of periodontal treatment within the previous 6 months;
- Continuous use of oral antiseptics, systemic antibiotics, corticosteroids, nonsteroidal anti-inflammatory drugs, immunosuppressive agents, estrogen, selective estrogen receptor modulators, or medications that may affect bone metabolism (such as alendronate, calcitonin, and others) within the previous 6 months;
- Presence of systemic conditions that may alter the host response to periodontal treatment (such as diabetes, human papillomavirus infection, or Down syndrome) or that require antibiotic prophylaxis before dental treatment (such as mitral valve prolapse);
- Use of probiotics within the previous 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acronym [*] Required if One Exists. It Will be Included in Parentheses at the End of the Brief Title.
This study aims to evaluate whether the oral administration of probiotics, in combination with conventional periodontal treatment (deep cleaning of the tooth root surfaces), can improve oral health and influence the relationship between oral and gut bacteria in individuals with periodontitis.
The study will include adults aged 30 years or older diagnosed with advanced periodontitis and receiving treatment at the School of Dentistry of Ribeirão Preto, University of São Paulo (FORP/USP). Individuals with systemic diseases that may interfere with the study outcomes, pregnant or breastfeeding women, smokers, recent former smokers, or individuals who have used antibiotics, probiotics, or certain medications within the previous six months will not be eligible to participate.
Read more
Participants will be randomly assigned to two groups: one group will receive conventional periodontal treatment alone, while the other will receive the same treatment combined with probiotic supplementation. Before and after treatment, periodontal health will be assessed, including the presence of dental plaque, bleeding, periodontal pocket depth, and clinical attachment levels. Inflammatory substances present in gingival fluid will also be analyzed to evaluate the response to treatment.
The findings of this study are expected to help clarify whether probiotics used as an adjunct to periodontal treatment can reduce inflammation and promote a more balanced relationship between oral and gut microorganisms, thereby contributing to improved periodontal health.
Read the detailed description
Periodontitis is a chronic inflammatory disease of multifactorial origin, characterized by the destruction of the tooth-supporting tissues as a result of the interaction between a dysbiotic biofilm and the host immunoinflammatory response. Recent evidence suggests that the oral microbiota may influence the gut microbiota through the oral-gut axis, contributing to local and systemic alterations. In this context, the use of probiotics as an adjunctive therapy to conventional periodontal treatment may favor the restoration of microbial balance and reduce inflammation.
The aim of this study is to evaluate the impact of systemic probiotic therapy, used as an adjunct to scaling and root planing (SRP), on the microbiological modulation of the oral-gut axis in patients with periodontitis. In addition, the effects of the intervention on periodontal clinical parameters, the immunoinflammatory profile, and the composition of the oral and gut microbiota will be investigated.
This randomized, placebo-controlled clinical trial will include 40 systemically healthy participants aged 30 years or older, diagnosed with generalized Stage III or IV, Grade B/C periodontitis, recruited at the School of Dentistry of Ribeirão Preto, University of São Paulo (FORP/USP). Participants will be randomly allocated into two groups: one group will receive scaling and root planing associated with the probiotic Bifidobacterium animalis subsp. lactis HN019, whereas the other group will receive the same periodontal treatment associated with placebo. The probiotic or placebo will be administered orally at a dose of one capsule per day for 30 days.
Periodontal clinical parameters will be recorded, including plaque index, bleeding index, probing depth, bleeding on probing, and clinical attachment level. The immunoinflammatory profile will be evaluated by quantifying CCL19, IL-6, TNF-α, IL-1β, and IL-17 in gingival crevicular fluid using multiplex assays (Luminex). To investigate modulation of the oral-gut axis, subgingival biofilm and fecal samples will be collected before and after the intervention for analysis of the oral and gut microbiota.
The results will allow us to determine whether the systemic administration of Bifidobacterium animalis subsp. lactis HN019 enhances the effects of non-surgical periodontal therapy, promoting clinical, immunological, and microbiological improvements compared with placebo.
- Conditions
- Periodontitis Stage IV, Periodontitis
- Being tested
- Probiotics Bifidobacterium animalis subsp. lactis HN019
- Keywords
- Periodontal Diseases, Gastrointestinal Microbiome, Probiotics, Bifidobacterium animalis, Periodontitis
- Medical subject headings
- Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics Bifidobacterium animalis subsp. lactis HN019Dietary supplement
The probiotic group will receive a dietary supplement manufactured by Aché Pharmaceuticals containing the strain Bifidobacterium animalis subsp. lactis HN019, while the control group will receive a placebo.
| Study group | Role | What they receive |
|---|---|---|
| Controle | Placebo comparator | The control group, which will receive scaling and root planing only, without probiotics. Receives: Dietary Supplement: Probiotics Bifidobacterium animalis subsp. lactis HN019 |
| Probiotics | Experimental | The probiotic group will receive probiotic supplementation as an adjunctive therapy to scaling and root planing. Receives: Dietary Supplement: Probiotics Bifidobacterium animalis subsp. lactis HN019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical periodontal parameters - Plaque index (PI)
Changes in clinical periodontal parameters including plaque index (PI) will be compared between the probiotic and placebo groups to evaluate the effect of adjunctive systemic probiotic therapy following scaling and root planing.
Measured: Baseline and 90 days after periodontal treatment.
Change in clinical periodontal parameters - Bleeding on Probing (BOP)
Changes in clinical periodontal parameters including bleeding on probing (POB) will be compared between the probiotic and placebo groups to evaluate the effect of adjunctive systemic probiotic therapy following scaling and root planning.
Measured: Baseline and 90 days after periodontal treatment.
Change in clinical periodontal parameters - Clinical Attachment Level (CAL)
Changes in clinical periodontal parameters including Clinical Attachment Level (CAL) will be compared between the probiotic and placebo groups to evaluate the effect of adjunctive systemic probiotic therapy following scaling and root planning.
Measured: Baseline and 90 days after periodontal treatment.
Secondary outcomes (1)
Change in immunoinflammatory biomarkers in gingival crevicular fluid
Changes in the concentrations of inflammatory and immunological biomarkers, including IL-6, TNF-α, IFN-γ, IL-10, IL-1β, and IL-8, measured in gingival crevicular fluid by Luminex immunoassays, will be compared between the probiotic and placebo groups to evaluate the influence of adjunctive systemic probiotic therapy on the host inflammatory response.
Measured: Baseline and 90 days after periodontal treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start25 Jun 2026
- Primary completion15 Jul 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontitis Stage IVStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomly allocated to two parallel groups in a 1:1 ratio. Both groups will receive scaling and root planing as conventional periodontal treatment. In addition, the experimental group will receive one daily capsule containing the probiotic Bifidobacterium animalis subsp. lactis HN019 for 30 days, while the control group will receive a placebo capsule with the same appearance and mode of administration. Participants will be followed for 90 days to evaluate clinical, immunological, and microbiological outcomes.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renata Persoli de Aguiar, University of Sao Paulo
- Investigators
- Renata P Aguiar, DDS, Spec, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792902
- Sponsor's protocol ID
- 98007426.0.0000.5419
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study coordinator (RPA) decided not to share information as she believes the patients prefer to keep them confidential.
Publications
Oliveira LF, Salvador SL, Silva PH, Furlaneto FA, Figueiredo L, Casarin R, Ervolino E, Palioto DB, Souza SL, Taba M Jr, Novaes AB Jr, Messora MR. Benefits of Bifidobacterium animalis subsp. lactis Probiotic in Experimental Periodontitis. J Periodontol. 2017 Feb;88(2):197-208. doi: 10.1902/jop.2016.160217. Epub 2016 Sep 23.
PubMed 27660886
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acronym [*] Required if One Exists. It Will be Included in Parentheses at the End of the Brief Title.
- ClinicalTrials.gov ID
- NCT07792902
- Acronym / sponsor ID
- 98007426.0.0000.5419
- Conditions
- Periodontitis Stage IV, Periodontitis
- Keywords
- Periodontal Diseases, Gastrointestinal Microbiome, Probiotics, Bifidobacterium animalis, Periodontitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 28 Aug 2026 (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.
This study aims to evaluate whether the oral administration of probiotics, in combination with conventional periodontal treatment (deep cleaning of the tooth root surfaces), can improve oral health and influence the relationship between oral and gut bacteria in individuals with periodontitis.
The study will include adults aged 30 years or older diagnosed with advanced periodontitis and receiving treatment at the School of Dentistry of Ribeirão Preto, University of São Paulo (FORP/USP). Individuals with systemic diseases that may interfere with the study outcomes, pregnant or breastfeeding women, smokers, recent former smokers, or individuals who have used antibiotics, probiotics, or certain medications within the previous six months will not be eligible to participate.
Participants will be randomly assigned to two groups: one group will receive conventional periodontal treatment alone, while the other will receive the same treatment combined with probiotic supplementation. Before and after treatment, periodontal health will be assessed, including the presence of dental plaque, bleeding, periodontal pocket depth, and clinical attachment levels. Inflammatory substances present in gingival fluid will also be analyzed to evaluate the response to treatment.
The findings of this study are expected to help clarify whether probiotics used as an adjunct to periodontal treatment can reduce inflammation and promote a more balanced relationship between oral and gut microorganisms, thereby contributing to improved periodontal health.
Detailed description
Periodontitis is a chronic inflammatory disease of multifactorial origin, characterized by the destruction of the tooth-supporting tissues as a result of the interaction between a dysbiotic biofilm and the host immunoinflammatory response. Recent evidence suggests that the oral microbiota may influence the gut microbiota through the oral-gut axis, contributing to local and systemic alterations. In this context, the use of probiotics as an adjunctive therapy to conventional periodontal treatment may favor the restoration of microbial balance and reduce inflammation.
The aim of this study is to evaluate the impact of systemic probiotic therapy, used as an adjunct to scaling and root planing (SRP), on the microbiological modulation of the oral-gut axis in patients with periodontitis. In addition, the effects of the intervention on periodontal clinical parameters, the immunoinflammatory profile, and the composition of the oral and gut microbiota will be investigated.
This randomized, placebo-controlled clinical trial will include 40 systemically healthy participants aged 30 years or older, diagnosed with generalized Stage III or IV, Grade B/C periodontitis, recruited at the School of Dentistry of Ribeirão Preto, University of São Paulo (FORP/USP). Participants will be randomly allocated into two groups: one group will receive scaling and root planing associated with the probiotic Bifidobacterium animalis subsp. lactis HN019, whereas the other group will receive the same periodontal treatment associated with placebo. The probiotic or placebo will be administered orally at a dose of one capsule per day for 30 days.
Periodontal clinical parameters will be recorded, including plaque index, bleeding index, probing depth, bleeding on probing, and clinical attachment level. The immunoinflammatory profile will be evaluated by quantifying CCL19, IL-6, TNF-α, IL-1β, and IL-17 in gingival crevicular fluid using multiplex assays (Luminex). To investigate modulation of the oral-gut axis, subgingival biofilm and fecal samples will be collected before and after the intervention for analysis of the oral and gut microbiota.
The results will allow us to determine whether the systemic administration of Bifidobacterium animalis subsp. lactis HN019 enhances the effects of non-surgical periodontal therapy, promoting clinical, immunological, and microbiological improvements compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Eligible participants will be randomly allocated to two parallel groups in a 1:1 ratio. Both groups will receive scaling and root planing as conventional periodontal treatment. In addition, the experimental group will receive one daily capsule containing the probiotic Bifidobacterium animalis subsp. lactis HN019 for 30 days, while the control group will receive a placebo capsule with the same appearance and mode of administration. Participants will be followed for 90 days to evaluate clinical, immunological, and microbiological outcomes.
| Arm | Type | Receives |
|---|---|---|
| Controle | Placebo comparator | Dietary Supplement: Probiotics Bifidobacterium animalis subsp. lactis HN019The control group, which will receive scaling and root planing only, without probiotics. |
| Probiotics | Experimental | Dietary Supplement: Probiotics Bifidobacterium animalis subsp. lactis HN019The probiotic group will receive probiotic supplementation as an adjunctive therapy to scaling and root planing. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Systemically healthy individuals;
- Age of 30 years or older;
- Both genders;
- At least 15 teeth, excluding third molars and teeth indicated for extraction
- At least 30% of the teeth presenting probing depth (PD) and clinical attachment loss (CAL) greater than or equal to 5 mm;
Key exclusion criteria (6 listed)
- Current smokers or former smokers who quit within the past 5 years;
- Pregnant or breastfeeding women;
- History of periodontal treatment within the previous 6 months;
- Continuous use of oral antiseptics, systemic antibiotics, corticosteroids, nonsteroidal anti-inflammatory drugs, immunosuppressive agents, estrogen, selective estrogen receptor modulators, or medications that may affect bone metabolism (such as alendronate, calcitonin, and others) within the previous 6 months;
- Presence of systemic conditions that may alter the host response to periodontal treatment (such as diabetes, human papillomavirus infection, or Down syndrome) or that require antibiotic prophylaxis before dental treatment (such as mitral valve prolapse);
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 |
|---|---|---|
| Probiotics Bifidobacterium animalis subsp. lactis HN019The probiotic group will receive a dietary supplement manufactured by Aché Pharmaceuticals containing the strain Bifidobacterium animalis subsp. lactis HN019, while the control group will receive a placebo. | Dietary supplement | Controle, Probiotics |
Primary outcome
Change in clinical periodontal parameters - Plaque index (PI)
Time frame: Baseline and 90 days after periodontal treatment.
Changes in clinical periodontal parameters including plaque index (PI) will be compared between the probiotic and placebo groups to evaluate the effect of adjunctive systemic probiotic therapy following scaling and root planing.
Change in clinical periodontal parameters - Bleeding on Probing (BOP)
Time frame: Baseline and 90 days after periodontal treatment.
Changes in clinical periodontal parameters including bleeding on probing (POB) will be compared between the probiotic and placebo groups to evaluate the effect of adjunctive systemic probiotic therapy following scaling and root planning.
Change in clinical periodontal parameters - Clinical Attachment Level (CAL)
Time frame: Baseline and 90 days after periodontal treatment.
Changes in clinical periodontal parameters including Clinical Attachment Level (CAL) will be compared between the probiotic and placebo groups to evaluate the effect of adjunctive systemic probiotic therapy following scaling and root planning.
1 secondary outcome
Change in immunoinflammatory biomarkers in gingival crevicular fluid
Time frame: Baseline and 90 days after periodontal treatment.
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 28 Aug 2026.
- Results publication: PubMed 27660886Oliveira LF, Salvador SL, Silva PH, Furlaneto FA, Figueiredo L, Casarin R, Ervolino E, Palioto DB, Souza SL, Taba M Jr, Novaes AB Jr, Messora MR. Benefits of Bifidobacterium animalis subsp. lactis Probiotic in Experimental Periodontitis. J Periodontol. 2017 Feb;88(2):197-208. doi: 10.1902/jop.2016.160217. Epub 2016 Sep 23.
- Individual participant dataSharing planned: No. The study coordinator (RPA) decided not to share information as she believes the patients prefer to keep them confidential.
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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.
Renata P Aguiar, DDS, Spec principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Probiotics Bifidobacterium animalis subsp. lactis HN019 in people with Periodontitis Stage IV and Periodontitis, run by University of Sao Paulo at 1 site in Brazil.
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 7 inclusion and 6 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 28 Aug 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in clinical periodontal parameters - Plaque index (PI) (time frame: Baseline and 90 days after periodontal treatment.). The study lists 3 primary outcomes in all. 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 NCT07792902, which also lists 1 linked publication.
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 28 Aug 2026.