ClinicalTrials.gg
CompletedNCT07551115Updated Nov 2, 2026

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

An observational study in Gingivitis and Periodontal Diseases and Periodontitis, sponsored by Abant Izzet Baysal University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Abant Izzet Baysal University · Observational

Updated Nov 2, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓

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Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 96 studies in Gingivitis with a site in Turkey — 18 open to participants now, 20 under way, none of them phase 3. Gingivitis · Turkey.

Enrollment
16th of 58
120 · median 75
Started
2025
with 16 others
Observational
58 of 96
11 open now
Registered
67th of 96
by date
Lead sponsor
8 of 96
Abant Izzet Baysal University

Among the 96 studies in Gingivitis with a site in Turkey, this one is the 16th largest by enrollment of the 58 observational ones that give a count, is one of 17 that started in 2025, is one of 58 observational ones, and was the 67th registered.

Gingivitis

631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.

Browse Gingivitis studies →

Open to participants now

18 of the 96 studies in Gingivitis with a site in Turkey are open now. Recruiting first, the newest first:

13 more — sign in →

All 18 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 53 Gingivitis studies recruiting now, 15 (28%) set no upper age limit and 36 (68%) stop at 75 or younger; 11 take children under 18; 35 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Gingivitis and Periodontal Diseases
  • Periodontitis

Keywords

  • gingivitis
  • periodontitis
  • Entamoeba Gingivalis
  • Trichomonas Tenax
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 therapy or having a serious systemic immune deficiency.
  • Pregnancy or breastfeeding.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
120 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Diagnostic testClinical Periodontal Evaluation

    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.

  • 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.

06

What researchers measure

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.

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

07

Study locations

1 site
  • Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Periodontology
    Bolu, Gölköy 14030, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Dec 2025 to primary completion in Jun 2026, 5 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 2, 2026: primary completion Jul 2026 → Jun 2026 and completion Sep 2026 → Jun 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 20, 2026
First posted
Apr 24, 2026
StartActual
Dec 22, 2025
Primary completionActual
Jun 17, 2026was Jul 2026
CompletionActual
Jun 30, 2026was Sep 2026
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Nov 2, 2026
Primary completion
Jul 2026→Jun 17, 2026 (actual)
Nov 2, 2026
Study completion
Sep 2026→Jun 30, 2026 (actual)
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Recruiting→Completed
    Primary completion Jul 2026→Jun 17, 2026 (now actual)
    Study completion Sep 2026→Jun 30, 2026 (now actual)
    + 2 other changes: contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07551115
Responsible party
Bilge MERACI YILDIRAN (Assistant Professor, Abant Izzet Baysal University) — Principal investigator
First posted
Apr 24, 2026
Start date
Dec 22, 2025
Primary completion
Jun 17, 2026
Completion
Jun 30, 2026
Last update
Nov 2, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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