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

NCT07579338 | Enrolling By Invitation

• 2 other identifiers: 2/5/2026Sarah
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

periodontitis; Plaque; E.saphenum; P. gingivalis

Outcome Measures

Primary Outcomes (1)

• The level of E. saphenum in periodontitis and periodontal health groups.

  Measuring the level of E. saphenum and P. ginigvalis in study groups using Real-time PCR

  8 MONTHS

Secondary Outcomes (1)

• Comparing the level of E. saphenum and P. gingivalis between study groups.

  8 months

Study Arms (2)

Peiordontal health

In the control group, the participants were diagnosed periodontal health characterized by BOP \< 10%, PPD ≤ 3mm, and intact periodontium with no probable attachment loss (Chapple et al., 2018)

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

Periodontitis

Participants were diagnosed as periodontitis when they have interdental CAL detectable at ≥2 non-adjacent teeth, or facial and/or oral CAL ≥3 mm associated with pocketing \>3mm detectable at ≥ 2 teeth. The diagnosis statement was: Generalized periodontitis (\>30% of teeth having CAL), Unstable status (having at least one site with PPD ≥5 mm or PPD ≥4 mm with BOP), at stages I-IV (Tonetti, Greenwell and Kenneth S. Kornman, 2018)

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

Interventions

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 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 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.

Peiordontal health; Periodontitis

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study is an observational case-control study. Patients with generalized unstable periodontitis, at any grade, with (\>4 mm) probing pocket depths (PPD), as well as periodontal health participants, will be recruited from the Department of Periodontics, College of Dentistry, University of Babylon. A written consent forms will be obtained from all participants. Ethical approval will be obtained.

You may qualify if:

• (1) Participants aged \> 30 years old. (2) Participants who have at least 20 teeth

You may not qualify if:

• \) Participants who have active caries. (2) Participants who are undergoing orthodontic treatment. (3) Participants with a history of antibiotic use within the last three months will not be eligible.
• (4) Participants with a history of valve replacement which requires prophylactic antibiotic coverage. (5) Participants who require systemic or topical non-steroidal anti-inflammatory drugs within the past three months. Participants who are pregnant or lactating women. (6) Participants with a history of alcohol use. (7) Participants who had periodontal therapy within the last six months

Sponsors & Collaborators

• Sarah Al-Rihaymee: lead

Study Sites (1)

University of babylon

Hillah, Babel, 3001, Iraq

Location

Related Publications (1)

• Castillo Y, Delgadillo NA, Neuta Y, Iniesta M, Sanz M, Herrera D, Pianeta R, Lafaurie GI, Castillo DM. Design and validation of a quantitative polymerase chain reaction test for the identification and quantification of uncultivable bacteria associated with periodontitis. Arch Oral Biol. 2023 Oct;154:105758. doi: 10.1016/j.archoralbio.2023.105758. Epub 2023 Jul 4.

  PMID: 37419062 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

IR (1)