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Detection And Quantification of Eubacterium Saphenum and Porphyromonas Gingivalis In Periodontal Health and Disease

NCT07579338 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 148

Last updated 2026-05-12

No results posted yet for this study

Summary

This case-control study will be conducted between January and June 2026 and will include 148 participants aged over 30 years to investigate differences between individuals with periodontitis (n = 111) and those with periodontal health (n = 37). Participants will be selected based on strict inclusion and exclusion criteria to minimize confounding factors, and ethical approval along with informed consent will be obtained prior to participation. Periodontitis will be diagnosed according to the 2017 classification criteria, requiring clinical attachment loss and periodontal pocketing, while periodontal health will be defined by minimal bleeding on probing, shallow pocket depths, and absence of attachment loss. The sample size will be determined using G\*Power to ensure adequate statistical power.

Clinical periodontal parameters-including plaque index, gingival bleeding index, probing pocket depth, and clinical attachment loss-will be recorded using standardized methods at multiple sites per tooth by calibrated examiners to ensure reliability. Following clinical assessment, subgingival biofilm samples will be collected using sterile paper points under controlled conditions and stored at -80°C for subsequent real-time PCR analysis. Calibration procedures, including inter- and intra-examiner agreement assessed by intraclass correlation coefficients, will be implemented to enhance measurement consistency. Overall, the study will combine rigorous clinical evaluation with molecular techniques to enable a comprehensive assessment of periodontal status and associated microbiological factors.

Conditions

  • Periodontitis
  • Periodontal Health

Interventions

DIAGNOSTIC_TEST

Microbiological sampling After recording the clinical periodontal parameters, subgingival biofilm samples were collected. After selecting the sampling site, it was isolated with cotton rolls to keep i

Microbiological sampling After recording the clinical periodontal parameters, subgingival biofilm samples were collected. After selecting the sampling site, it was isolated with cotton rolls to keep it dry and avoid saliva contamination. Then, a sterile paper point will be gently inserted into the selected sites reaching the base of the pocket and will be kept for 30 seconds. Then, the paper point will be carefully withdrawn and placed immediately into a sterile tube containing a preservative solution. The tube will be labeled with details, including the patient ID, site location, and date, and then sealed tightly to prevent contamination. The sample was stored at -80°C to preserve DNA quality for subsequent Real time-PCR analysis.

Sponsors & Collaborators

  • Sarah Al-Rihaymee

    lead OTHER

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-06-01
Completion
2026-08-01

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07579338 on ClinicalTrials.gov