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

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.

NCT Number	NCT07579338
Lead Sponsor	Sarah Al-Rihaymee
Conditions	Periodontitis, Periodontal Health
Enrollment	148 participants
Start Date	2026-01-31
Primary Completion	2026-06-01 (estimated)
Study Completion	2026-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-12