Association Between Periodontal Status and the Prevalence of Entamoeba Gingivalis and Trichomonas Tenax

NCT07551115 | Recruiting

• 1 other identifier: BAIBU-SBF-BMY-02
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study aims to investigate the prevalence and clinical significance of two oral protozoa, Entamoeba gingivalis and Trichomonas tenax, among patients attending the Bolu Abant İzzet Baysal University Faculty of Dentistry, Department of Periodontology. While the oral microbiome typically maintains a delicate balance, disruptions in this ecosystem are thought to trigger periodontal diseases. Recent evidence suggests that these parasites may contribute to increased inflammation and tissue destruction, potentially playing a role in the etiology of gingivitis and periodontitis. The study will include 120 participants aged 18 and older who meet the inclusion criteria. Following the collection of demographic data and oral hygiene habits via a questionnaire, a single calibrated examiner will perform comprehensive clinical periodontal examinations. Measurements will include Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Probing Pocket Depth (PPD), Clinical Attachment Loss (CAL), and Gingival Recession (GR) based on the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions. To detect the presence of parasites, unstimulated whole saliva samples and subgingival plaque samples from the deepest periodontal pockets will be collected from each participant. These samples will be analyzed immediately at the Parasitology Laboratory using light microscopy (10X and 40X magnification) to identify live trophozoites. By evaluating the relationship between parasite prevalence and periodontal status, this research aims to contribute to the limited literature on oral protozoa in Turkey and increase clinical awareness regarding their impact on oral health.

Conditions

Gingivitis and Periodontal Diseases; Periodontitis

Keywords

gingivitis; periodontitis; Entamoeba Gingivalis; Trichomonas Tenax

Outcome Measures

Primary Outcomes (1)

• Prevalence of Entamoeba gingivalis and Trichomonas tenax

  The presence or absence of live trophozoites of Entamoeba gingivalis and Trichomonas tenax will be determined through light microscopic examination (10X and 40X magnification) of saliva and subgingival plaque samples. The outcome will be reported as the percentage (%) of participants testing positive for each parasite within the different periodontal health groups.

  Baseline (at the time of clinical examination and sample collection, typically within 1 hour).

Study Arms (3)

Periodontally Healthy

Systemically healthy individuals with no clinical signs of gingival inflammation (BOP \< 10%), no clinical attachment loss, and no probing depths \> 3 mm.

Diagnostic Test: Clinical Periodontal Evaluation; Procedure: Microscopic Examination of Oral Protozoa

Gingivitis

Patients diagnosed with dental plaque-induced gingivitis characterized by bleeding on probing (BOP ≥ 10%) and no clinical attachment loss or radiographic bone loss, according to the 2017 World Workshop classification.

Diagnostic Test: Clinical Periodontal Evaluation; Procedure: Microscopic Examination of Oral Protozoa

Periodontitis

Patients diagnosed with periodontitis (Stages I-IV) characterized by interdental clinical attachment loss, probing depths ≥ 4 mm, and radiographic evidence of alveolar bone loss.

Diagnostic Test: Clinical Periodontal Evaluation; Procedure: Microscopic Examination of Oral Protozoa

Interventions

Clinical Periodontal Evaluation DIAGNOSTIC_TEST

Comprehensive periodontal examination including Plaque Index, Gingival Index, Bleeding on Probing, Probing Pocket Depth, and Clinical Attachment Loss measurements using a Williams periodontal probe according to the 2017 World Workshop Classification.

Gingivitis; Periodontally Healthy; Periodontitis

Microscopic Examination of Oral Protozoa PROCEDURE

Collection of unstimulated saliva and subgingival plaque samples followed by immediate light microscopy examination (10X and 40X magnification) to detect the presence and frequency of Entamoeba gingivalis and Trichomonas tenax trophozoites.

Gingivitis; Periodontally Healthy; Periodontitis

Eligibility Criteria

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

Study Population

Patients aged 18 and older who applied to the Bolu Abant İzzet Baysal University Faculty of Dentistry, Department of Periodontology, and met the inclusion criteria.

You may qualify if:

• Participants aged 18 years or older.
• Having at least 10 natural teeth.
• Willingness to undergo periodontal examination and providing written informed consent.
• Includes both periodontally healthy individuals and patients with gingivitis or periodontitis.

You may not qualify if:

• Use of systemic antibiotics within the last 3 months.
• Use of chlorhexidine or similar antiseptic mouthwashes within the last month.
• Having received any periodontal treatment within the last 3 months.
• Receiving immunosuppressive therapy or having a serious systemic immune deficiency.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Periodontology

Bolu, Gölköy, 14030, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Subgingival plaque and unstimulated saliva samples for microscopic examination.

MeSH Terms

Conditions

Gingivitis; Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Bilge Meracı Yıldıran, Asst. Prof.

CONTACT

+905366580192; bilgemeraci@ibu.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 24, 2026
• Study Start: December 22, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)