Understanding links between severe periodontitis and gut bacteria and barrier function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will enroll 20 adults with Stage III/IV periodontitis and characterize their oral and gut health using periodontal exams, breath tests for SIBO, and blood tests for gut barrier biomarkers. The study is prospective and exploratory, aiming to describe associations rather than prove causation. Participants will be followed to see if improvements in periodontal health align with changes in SIBO status and biomarker levels. Data on symptoms and lifestyle will help interpret the findings. No healthy control group is included, and results will inform future studies on oral-gut interactions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Ambulatoriul de Stomatologie al SCJU Cluj-Napoca, România
  Cluj-Napoca, Romania Recruiting

Study contacts

• Study coordinator: Damaris Anton, Doctor of Dental Medicine
• Email: damaris.anton@elearn.umfcluj.ro
• Phone: +40770588626

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.