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

Prevalence of Entamoeba Gingivalis and Trichomonas Tenax in Saliva and Subgingival Plaque Samples Among Periodontology Patients: A Prospective Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07551115
Enrollment
120
Registered
2026-04-24
Start date
2025-12-22
Completion date
2026-09-01
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis and Periodontal Diseases, Periodontitis

Keywords

gingivitis, periodontitis, Entamoeba Gingivalis, Trichomonas Tenax

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.

Detailed description

The primary objective of this single-center, cross-sectional, prospective study is to evaluate the frequency of Entamoeba gingivalis and Trichomonas tenax in patients with different periodontal health statuses. Despite being the first protozoa identified in the oral cavity, the role of these parasites in the pathogenesis of periodontal destruction remains a critical area of investigation. This study seeks to correlate the presence of these protozoa with clinical periodontal parameters and patient-related factors. 1. Patient Selection and Recruitment: A total of 120 patients who apply to the Bolu Abant İzzet Baysal University Faculty of Dentistry, Department of Periodontology, will be screened. Following written informed consent, a detailed questionnaire will be administered to collect data on: Demographics (Age, sex, education, and economic status) Medical history (Systemic diseases, smoking, and pregnancy status) Oral hygiene habits and recent use of antibiotics or antiseptic mouthwashes. 2. Clinical Periodontal Examination: Periodontal diagnosis will be performed according to the "2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions." All clinical measurements will be conducted by a single calibrated examiner using a Williams periodontal probe. The following parameters will be recorded: Plaque index (PI): Evaluated at 4 sites per tooth (0-3 scale). Gingival index (GI): Assessment of gingival inflammation (0-3 scale). Bleeding on probing (BOP): Presence/absence of bleeding within 10 seconds of probing, expressed as a percentage. Probing pocket depth (PPD): Distance from the gingival margin to the base of the pocket (6 sites per tooth). Clinical attachment loss (CAL): Distance from the cemento-enamel junction to the base of the pocket. Gingival recession: Distance from the cemento-enamel junction to the gingival margin. 3. Sample Collection and Laboratory Analysis: Two types of biological samples will be collected from each participant: Subgingival plaque: After isolating the area with cotton rolls and removing supragingival plaque, samples will be collected from the 4 deepest periodontal pockets using sterile curettes and transferred into tubes containing 0.9% NaCl. Unstimulated saliva: Approximately 2 mL of whole saliva will be collected after at least 30 minutes of no food intake or mouth rinsing. Samples will be transported immediately to the Parasitology Laboratory at Bolu Abant İzzet Baysal University Faculty of Medicine. Three slide preparations per sample will be examined under a light microscope (10X and 40X magnification) to identify the presence of live trophozoites. 4. Sample Size and Power Analysis: The sample size of 120 was determined based on similar prevalence studies in the literature.

Interventions

PROCEDUREMicroscopic Examination of Oral Protozoa

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.

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.

Sponsors

Abant Izzet Baysal University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Entamoeba gingivalis and Trichomonas tenaxBaseline (at the time of clinical examination and sample collection, typically within 1 hour).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.

Countries

Turkey (Türkiye)

Contacts

CONTACTBilge Meracı Yıldıran, Asst. Prof.
bilgemeraci@ibu.edu.tr+905366580192

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026