Trial · NCT07907224
Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis
NCT07907224, Recruiting, Iuliu Hatieganu University of Medicine and Pharmacy
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis. Trials, record NCT07907224. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07907224
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis
- NCT number
- NCT07907224
- Status
- Recruiting
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Conditions
- Periodontitis (Stage 3), Periodontitis Stage IV, SIBO
- First posted
- 2026-10-30
- Last updated
- 2026-11-04
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Small Intestinal Bacterial Overgrowth (SIBO) Prevalence Assessed by Hydrogen and Methane Breath Testing | 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. |
| Secondary | Serum Zonulin Concentration Measured by Enzyme-Linked Immunosorbent Assay | At baseline, before periodontal treatment, and 6-8 weeks after completion of periodontal treatment. | 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. |
| Secondary | Serum Lipopolysaccharide-Binding Protein Concentration Measured by Enzyme-Linked Immunosorbent Assay | At baseline, before periodontal treatment, and 6-8 weeks after completion of periodontal treatment. | 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. |
| Secondary | Periodontal Probing Pocket Depth Measured by Periodontal Probing | At baseline, before periodontal treatment, and 6-8 weeks after completion of periodontal treatment. | 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. |
| Secondary | Clinical Attachment Level Measured by Periodontal Probing | At baseline, before periodontal treatment, and 6-8 weeks after completion of periodontal treatment. | 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. |
| Secondary | Bleeding on Probing Percentage Assessed During Periodontal Examination | At baseline, before periodontal treatment, and 6-8 weeks after completion of periodontal treatment. | 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. |
| Secondary | Body Mass Index (BMI) Calculated from Weight and Height Measurements | At baseline, before periodontal treatment. | 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. |
| Secondary | Gastrointestinal Symptom Severity Assessed Using the Gastrointestinal Symptom Rating Scale (GSRS) | At baseline, before periodontal treatment. | 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. |
| Secondary | Gastrointestinal Symptom Severity Assessed Using the Visual Analog Scale for Irritable Bowel Syndrome (VAS-IBS) | At baseline, before periodontal treatment. | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42356145 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07907224
GET https://conductscience.org/api/trials/v1/NCT07907224/registered