Periodontitis (Stage 3)MIRANCT07907224
Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis
An observational study of Periodontitis (Stage 3) and Periodontitis Stage IV, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Periodontitis is a chronic inflammatory disease characterized by dysbiotic subgingival biofilms, inflammation, and progressive destruction of the tooth-supporting tissues. Beyond the local periodontal lesion, periodontal inflammation may contribute to systemic inflammatory burden through the dissemination of microbial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis (Stage 3), Periodontitis Stage IV, SIBO
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteRomania
- Study dates
- 2 Oct 2026to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults diagnosed with Stage III/IV periodontitis who meet the study's eligibility criteria will be recruited from the Outpatient Dental Clinic of the County Emergency Clinical Hospital (SCJU) Cluj-Napoca, Romania. Participants will undergo periodontal clinical assessment, testing for small intestinal bacterial overgrowth (SIBO), and blood sampling for the assessment of selected serum biomarkers. Eligible participants will receive non-surgical periodontal therapy as specified in the study protocol.
Who may be able to join
- Adults aged ≥18 years.
- Diagnosis of Stage III/IV periodontitis, Grade B or C, according to the applicable periodontal classification criteria.
- Presence of sufficient dentition to permit a meaningful full-mouth periodontal examination.
- Ability and willingness to perform the breath test and provide blood samples and questionnaire data.
- Written informed consent.
- Patients with stable chronic systemic conditions may be included, provided that the condition is clinically controlled and does not meet any exclusion criterion. Relevant systemic diseases and concomitant medications will be recorded and considered as potential confounding factors.
Who cannot join
- Uncontrolled or severe systemic disease likely to substantially affect periodontal inflammation, intestinal microbiota, intestinal barrier function, systemic inflammatory status, or the safety of periodontal treatment.
- Antibiotic, systemic antifungal, or probiotic therapy within the preceding 4 weeks.
- Recent periodontal treatment that could materially influence baseline periodontal or biological measurements.
- Diagnosed inflammatory bowel disease, celiac disease, major intestinal surgery, or another major gastrointestinal condition that would substantially interfere with interpretation of SIBO or intestinal barrier-related outcomes.
- Current pregnancy or breastfeeding.
- Other condition or treatment judged by the investigator to materially interfere with the study outcomes or procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Ambulatoriul de Stomatologie al SCJU Cluj-Napoca, România
Cluj-Napoca
Damaris Anton, Doctor of Dental Medicine, +40770588626, damaris.anton@elearn.umfcluj.ro
About this study
Official title: The Intestinal Microbiome: From Systemic Impact to Periodontal Supporting Tissues
Periodontitis is a chronic inflammatory disease characterized by dysbiotic subgingival biofilms, inflammation, and progressive destruction of the tooth-supporting tissues. Beyond the local periodontal lesion, periodontal inflammation may contribute to systemic inflammatory burden through the dissemination of microbial products and inflammatory mediators.
The oral cavity and intestinal tract are closely connected through continuous microbial exposure, swallowing of oral microorganisms, host immune pathways, and systemic circulation. Emerging evidence suggests that periodontal inflammation may be associated with alterations of the intestinal microbial environment and gut barrier function. However, the human evidence remains heterogeneous and does not currently establish a causal relationship between periodontitis and intestinal dysbiosis or small intestinal bacterial overgrowth (SIBO).
Read more
SIBO represents an abnormal increase and/or alteration of bacterial populations in the small intestine and may be associated with gastrointestinal symptoms and intestinal microbial imbalance. The occurrence of SIBO in patients with advanced periodontitis has not been adequately characterized. Consequently, determining how frequently SIBO is detected in a clinically well-characterized cohort of participants with Stage III periodontitis may provide useful exploratory data and may support future controlled studies.
Alterations in the intestinal microbial environment may be accompanied by changes in intestinal barrier function and increased systemic exposure to bacterial products. Zonulin has been investigated as a biomarker related to intestinal barrier regulation, while lipopolysaccharide-binding protein (LBP) may provide information regarding systemic exposure to bacterial products. These biomarkers should be interpreted as indirect biological indicators rather than as direct measurements of intestinal permeability.
The present study therefore approaches the oral-gut-systemic interface from an exploratory clinical perspective. It does not aim to demonstrate that periodontitis causes SIBO. Instead, it seeks to characterize the occurrence of SIBO in participants with severe periodontitis and to explore whether SIBO is accompanied by alterations in intestinal barrier-related biomarkers and systemic exposure to bacterial products. The longitudinal component will further examine whether improvement in periodontal clinical status following routine, clinically indicated periodontal therapy is accompanied by changes in SIBO status and these biological markers.
Read the detailed description
Periodontitis is a chronic inflammatory disease associated with dysbiotic changes in the oral microbiome. Interactions between the oral and intestinal microbial environments may influence host inflammatory responses and intestinal barrier function. However, the clinical relationships between severe periodontitis, small intestinal bacterial overgrowth (SIBO), and circulating biomarkers related to intestinal barrier function and bacterial exposure remain insufficiently characterized.
This study will investigate these relationships in adults with Stage III/IV periodontitis, Grade B or C. The study will include 20 participants in a single prospective cohort, without a healthy control or comparison group. The study is exploratory and is intended to characterize clinical and biological associations rather than establish causal relationships.
The research will integrate standardized periodontal examination with hydrogen and methane breath testing using lactulose and/or glucose. Serum zonulin and lipopolysaccharide-binding protein (LBP) will be assessed as biomarkers related to intestinal barrier function and systemic exposure to bacterial products, respectively. Gastrointestinal symptoms and relevant clinical and lifestyle characteristics will also be considered when interpreting the findings.
A longitudinal component will examine whether changes in periodontal clinical status following routine, clinically indicated periodontal therapy are accompanied by changes in SIBO status and serum biomarker levels. Follow-up assessment is planned approximately 6-8 weeks after completion of etiological periodontal treatment.
The study is expected to provide preliminary clinical data on the potential relationships between periodontal disease, intestinal microbial alterations, and systemic inflammatory processes. The findings may help generate hypotheses for future larger controlled studies.
- Conditions
- Periodontitis (Stage 3), Periodontitis Stage IV, SIBO
- Keywords
- periodontitis, SIBO, intestinal permeability, oral-gut axis, severe periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with severe periodontitis (stage III/IV) | This study includes a single group of patients with Stage III/IV periodontitis. Participants will undergo a comprehensive periodontal examination, assessment for small intestinal bacterial overgrowth (SIBO) using hydrogen and methane breath testing, and blood sampling for the assessment of serum biomarkers related to intestinal barrier function and systemic inflammation, including zonulin and lipopolysaccharide (LPS). Gastrointestinal symptoms will also be assessed using a questionnaire. Participants will receive standard non-surgical periodontal therapy, including scaling and root planing, according to clinical indications. Periodontal clinical parameters and selected serum biomarkers will be reassessed 6-8 weeks after treatment. No control group is included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small Intestinal Bacterial Overgrowth (SIBO) Prevalence Assessed by Hydrogen and Methane Breath Testing
The presence of small intestinal bacterial overgrowth (SIBO) will be assessed using a hydrogen and methane breath test following administration of the specified test substrate. Breath samples will be collected at predefined intervals and analyzed for hydrogen and methane concentrations. SIBO status will be classified as positive or negative according to the prespecified diagnostic criteria. Prevalence will be calculated as the percentage of participants with a positive test result among all participants evaluated at baseline.
Measured: At baseline, before periodontal treatment.
Secondary outcomes (8)
Serum Zonulin Concentration Measured by Enzyme-Linked Immunosorbent Assay
Serum zonulin concentrations will be determined using an enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected and processed to obtain serum for quantitative determination of zonulin. Measurements will be performed at baseline, before periodontal treatment, and at follow-up, 6-8 weeks after completion of periodontal treatment. Changes in serum zonulin concentrations between the two time points will be evaluated and analyzed in relation to SIBO status and periodontal clinical parameters.
Measured: At baseline, before periodontal treatment, and 6-8 weeks after completion of periodontal treatment.
Serum Lipopolysaccharide-Binding Protein Concentration Measured by Enzyme-Linked Immunosorbent Assay
Serum lipopolysaccharide-binding protein (LBP) concentrations will be determined using an enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected and processed to obtain serum for quantitative determination of LBP. Measurements will be performed at baseline, before periodontal treatment, and at follow-up, 6-8 weeks after completion of periodontal treatment. Changes in serum LBP concentrations between the two time points will be evaluated and analyzed in relation to SIBO status and periodontal clinical parameters.
Measured: At baseline, before periodontal treatment, and 6-8 weeks after completion of periodontal treatment.
Periodontal Probing Pocket Depth Measured by Periodontal Probing
Periodontal probing pocket depth (PPD) will be assessed using a periodontal probe at the examined tooth sites. PPD is defined as the distance, in millimeters, from the gingival margin to the bottom of the periodontal pocket. Measurements will be recorded for each examined site, and the mean PPD per participant will be calculated for analysis.
Measured: At baseline, before periodontal treatment, and 6-8 weeks after completion of periodontal treatment.
Clinical Attachment Level Measured by Periodontal Probing
Clinical attachment level (CAL) will be assessed using a periodontal probe at the examined tooth sites. CAL is defined as the distance, in millimeters, from the cemento-enamel junction to the bottom of the periodontal pocket. Measurements will be recorded for each examined site, and the mean CAL per participant will be calculated for analysis.
Measured: At baseline, before periodontal treatment, and 6-8 weeks after completion of periodontal treatment.
Bleeding on Probing Percentage Assessed During Periodontal Examination
Bleeding on probing (BOP) will be assessed following periodontal probing at the examined tooth sites. The presence or absence of bleeding will be recorded for each site. The BOP percentage will be calculated as the number of sites presenting bleeding divided by the total number of examined sites, multiplied by 100.
Measured: At baseline, before periodontal treatment, and 6-8 weeks after completion of periodontal treatment.
Body Mass Index (BMI) Calculated from Weight and Height Measurements
Body mass index (BMI) will be calculated for each participant by dividing body weight in kilograms by the square of height in meters (kg/m²). Weight and height will be measured using standard anthropometric procedures. BMI values will be recorded at baseline and analyzed as potential clinical confounders in relation to SIBO status and periodontal clinical parameters.
Measured: At baseline, before periodontal treatment.
Gastrointestinal Symptom Severity Assessed Using the Gastrointestinal Symptom Rating Scale (GSRS)
Gastrointestinal symptoms will be assessed at baseline using the Gastrointestinal Symptom Rating Scale (GSRS), a standardized questionnaire evaluating the severity of gastrointestinal symptoms across different domains. Participants will complete the questionnaire, and the total GSRS score will be calculated according to the instrument's scoring instructions. The total score will be used to characterize gastrointestinal symptom burden and explore its relationship with SIBO status and periodontal clinical parameters.
Measured: At baseline, before periodontal treatment.
Gastrointestinal Symptom Severity Assessed Using the Visual Analog Scale for Irritable Bowel Syndrome (VAS-IBS)
Gastrointestinal symptoms will be assessed at baseline using the Romanian version of the VAS-IBS questionnaire (ROME IV). The questionnaire evaluates abdominal pain frequency, gastrointestinal symptom severity (including abdominal pain, diarrhea, constipation, bloating and gas, and nausea and vomiting), stool consistency, emotional well-being, the impact of gastrointestinal symptoms on daily life, and bowel-related symptoms. Responses will be recorded and analyzed according to the individual scoring scales and response categories specified in the questionnaire. The results will be used to characterize gastrointestinal symptom burden and explore its relationship with SIBO status and periodontal clinical parameters.
Measured: At baseline, before periodontal treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start2 Oct 2026
- Primary completion29 Oct 2027 (estimated)
- Study completion30 Sep 2029 (estimated)
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 3)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anton Damaris, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907224
- Sponsor's protocol ID
- AVZ107
- Acronym
- MIRA
- Status last verified
- Nov 2026
- First submitted
- 25 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anton D, Baciut M, Almasan O. The Oral-Gut Microbiome Connection in Patients with Periodontitis: A Systematic Review. Medicina (Kaunas). 2026 Jun 10;62(6):1133. doi: 10.3390/medicina62061133.
PubMed 42356145
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intestinal Microbiome: From Systemic Impact to Periodontal Supporting Tissues
- ClinicalTrials.gov ID
- NCT07907224
- Acronym / sponsor ID
- MIRA / AVZ107
- Conditions
- Periodontitis (Stage 3), Periodontitis Stage IV, SIBO
- Keywords
- periodontitis, SIBO, intestinal permeability, oral-gut axis, severe periodontitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 2 Oct 2026 (actual)
- Primary completion
- 29 Oct 2027 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 30 Oct 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.
Periodontitis is a chronic inflammatory disease characterized by dysbiotic subgingival biofilms, inflammation, and progressive destruction of the tooth-supporting tissues. Beyond the local periodontal lesion, periodontal inflammation may contribute to systemic inflammatory burden through the dissemination of microbial products and inflammatory mediators.
The oral cavity and intestinal tract are closely connected through continuous microbial exposure, swallowing of oral microorganisms, host immune pathways, and systemic circulation. Emerging evidence suggests that periodontal inflammation may be associated with alterations of the intestinal microbial environment and gut barrier function. However, the human evidence remains heterogeneous and does not currently establish a causal relationship between periodontitis and intestinal dysbiosis or small intestinal bacterial overgrowth (SIBO).
SIBO represents an abnormal increase and/or alteration of bacterial populations in the small intestine and may be associated with gastrointestinal symptoms and intestinal microbial imbalance. The occurrence of SIBO in patients with advanced periodontitis has not been adequately characterized. Consequently, determining how frequently SIBO is detected in a clinically well-characterized cohort of participants with Stage III periodontitis may provide useful exploratory data and may support future controlled studies.
Alterations in the intestinal microbial environment may be accompanied by changes in intestinal barrier function and increased systemic exposure to bacterial products. Zonulin has been investigated as a biomarker related to intestinal barrier regulation, while lipopolysaccharide-binding protein (LBP) may provide information regarding systemic exposure to bacterial products. These biomarkers should be interpreted as indirect biological indicators rather than as direct measurements of intestinal permeability.
The present study therefore approaches the oral-gut-systemic interface from an exploratory clinical perspective. It does not aim to demonstrate that periodontitis causes SIBO. Instead, it seeks to characterize the occurrence of SIBO in participants with severe periodontitis and to explore whether SIBO is accompanied by alterations in intestinal barrier-related biomarkers and systemic exposure to bacterial products. The longitudinal component will further examine whether improvement in periodontal clinical status following routine, clinically indicated periodontal therapy is accompanied by changes in SIBO status and these biological markers.
Detailed description
Periodontitis is a chronic inflammatory disease associated with dysbiotic changes in the oral microbiome. Interactions between the oral and intestinal microbial environments may influence host inflammatory responses and intestinal barrier function. However, the clinical relationships between severe periodontitis, small intestinal bacterial overgrowth (SIBO), and circulating biomarkers related to intestinal barrier function and bacterial exposure remain insufficiently characterized.
This study will investigate these relationships in adults with Stage III/IV periodontitis, Grade B or C. The study will include 20 participants in a single prospective cohort, without a healthy control or comparison group. The study is exploratory and is intended to characterize clinical and biological associations rather than establish causal relationships.
The research will integrate standardized periodontal examination with hydrogen and methane breath testing using lactulose and/or glucose. Serum zonulin and lipopolysaccharide-binding protein (LBP) will be assessed as biomarkers related to intestinal barrier function and systemic exposure to bacterial products, respectively. Gastrointestinal symptoms and relevant clinical and lifestyle characteristics will also be considered when interpreting the findings.
A longitudinal component will examine whether changes in periodontal clinical status following routine, clinically indicated periodontal therapy are accompanied by changes in SIBO status and serum biomarker levels. Follow-up assessment is planned approximately 6-8 weeks after completion of etiological periodontal treatment.
The study is expected to provide preliminary clinical data on the potential relationships between periodontal disease, intestinal microbial alterations, and systemic inflammatory processes. The findings may help generate hypotheses for future larger controlled studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with severe periodontitis (stage III/IV) | – | –This study includes a single group of patients with Stage III/IV periodontitis. Participants will undergo a comprehensive periodontal examination, assessment for small intestinal bacterial overgrowth (SIBO) using hydrogen and methane breath testing, and blood sampling for the assessment of serum biomarkers related to intestinal barrier function and systemic inflammation, including zonulin and lipopolysaccharide (LPS). Gastrointestinal symptoms will also be assessed using a questionnaire. Participants will receive standard non-surgical periodontal therapy, including scaling and root planing, according to clinical indications. Periodontal clinical parameters and selected serum biomarkers will be reassessed 6-8 weeks after treatment. No control group is included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with Stage III/IV periodontitis who meet the study's eligibility criteria will be recruited from the Outpatient Dental Clinic of the County Emergency Clinical Hospital (SCJU) Cluj-Napoca, Romania. Participants will undergo periodontal clinical assessment, testing for small intestinal bacterial overgrowth (SIBO), and blood sampling for the assessment of selected serum biomarkers. Eligible participants will receive non-surgical periodontal therapy as specified in the study protocol.
Key inclusion criteria (6 listed)
- Adults aged ≥18 years.
- Diagnosis of Stage III/IV periodontitis, Grade B or C, according to the applicable periodontal classification criteria.
- Presence of sufficient dentition to permit a meaningful full-mouth periodontal examination.
- Ability and willingness to perform the breath test and provide blood samples and questionnaire data.
- Written informed consent.
Key exclusion criteria (6 listed)
- Uncontrolled or severe systemic disease likely to substantially affect periodontal inflammation, intestinal microbiota, intestinal barrier function, systemic inflammatory status, or the safety of periodontal treatment.
- Antibiotic, systemic antifungal, or probiotic therapy within the preceding 4 weeks.
- Recent periodontal treatment that could materially influence baseline periodontal or biological measurements.
- Diagnosed inflammatory bowel disease, celiac disease, major intestinal surgery, or another major gastrointestinal condition that would substantially interfere with interpretation of SIBO or intestinal barrier-related outcomes.
- Current pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Small Intestinal Bacterial Overgrowth (SIBO) Prevalence Assessed by Hydrogen and Methane Breath Testing
Time frame: At baseline, before periodontal treatment.
The presence of small intestinal bacterial overgrowth (SIBO) will be assessed using a hydrogen and methane breath test following administration of the specified test substrate. Breath samples will be collected at predefined intervals and analyzed for hydrogen and methane concentrations. SIBO status will be classified as positive or negative according to the prespecified diagnostic criteria. Prevalence will be calculated as the percentage of participants with a positive test result among all participants evaluated at baseline.
8 secondary outcomes
Serum Zonulin Concentration Measured by Enzyme-Linked Immunosorbent Assay
Time frame: At baseline, before periodontal treatment, and 6-8 weeks after completion of periodontal treatment.
Serum Lipopolysaccharide-Binding Protein Concentration Measured by Enzyme-Linked Immunosorbent Assay
Time frame: At baseline, before periodontal treatment, and 6-8 weeks after completion of periodontal treatment.
Periodontal Probing Pocket Depth Measured by Periodontal Probing
Time frame: At baseline, before periodontal treatment, and 6-8 weeks after completion of periodontal treatment.
Clinical Attachment Level Measured by Periodontal Probing
Time frame: At baseline, before periodontal treatment, and 6-8 weeks after completion of periodontal treatment.
Bleeding on Probing Percentage Assessed During Periodontal Examination
Time frame: At baseline, before periodontal treatment, and 6-8 weeks after completion of periodontal treatment.
Body Mass Index (BMI) Calculated from Weight and Height Measurements
Time frame: At baseline, before periodontal treatment.
Gastrointestinal Symptom Severity Assessed Using the Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: At baseline, before periodontal treatment.
Gastrointestinal Symptom Severity Assessed Using the Visual Analog Scale for Irritable Bowel Syndrome (VAS-IBS)
Time frame: At baseline, before periodontal treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 42356145Anton D, Baciut M, Almasan O. The Oral-Gut Microbiome Connection in Patients with Periodontitis: A Systematic Review. Medicina (Kaunas). 2026 Jun 10;62(6):1133. doi: 10.3390/medicina62061133.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis (Stage 3) and Periodontitis Stage IV, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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 6 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: looking for participants now, as of the sponsor's last update on 4 Nov 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 Romania. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damaris Anton, Doctor of Dental Medicine (+40770588626, damaris.anton@elearn.umfcluj.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Small Intestinal Bacterial Overgrowth (SIBO) Prevalence Assessed by Hydrogen and Methane Breath Testing (time frame: At baseline, before periodontal treatment.). 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 NCT07907224, 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 4 Nov 2026.