Gingivitis and Periodontal DiseasesNCT07551115
Association Between Periodontal Status and the Prevalence of Entamoeba Gingivalis and Trichomonas Tenax
An observational study of Gingivitis and Periodontal Diseases and Periodontitis, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis and Periodontal Diseases, Periodontitis
- What is being tested?
- Clinical Periodontal Evaluation and Microscopic Examination of Oral Protozoa
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Dec 2025to 30 Jun 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Periodontology
Bolu, Gölköy, 14030
About this study
Official title: Prevalence of Entamoeba Gingivalis and Trichomonas Tenax in Saliva and Subgingival Plaque Samples Among Periodontology Patients: A Prospective Observational Study
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.
- 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.
- 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.
- 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.
- Sample Size and Power Analysis:
The sample size of 120 was determined based on similar prevalence studies in the literature.
- Conditions
- Gingivitis and Periodontal Diseases, Periodontitis
- Being tested
- Clinical Periodontal Evaluation, Microscopic Examination of Oral Protozoa
- Keywords
- gingivitis, periodontitis, Entamoeba Gingivalis, Trichomonas Tenax
- Medical subject headings
- Gingivitis, Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Periodontal EvaluationDiagnostic 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.
Microscopic Examination of Oral ProtozoaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Periodontally Healthy | Systemically healthy individuals with no clinical signs of gingival inflammation (BOP < 10%), no clinical attachment loss, and no probing depths > 3 mm. Receives: 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. Receives: 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. Receives: Diagnostic Test: Clinical Periodontal Evaluation; Procedure: Microscopic Examination of Oral Protozoa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (at the time of clinical examination and sample collection, typically within 1 hour).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start22 Dec 2025
- Primary completion17 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingivitis and Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge MERACI YILDIRAN, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551115
- Sponsor's protocol ID
- BAIBU-SBF-BMY-02
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Entamoeba Gingivalis and Trichomonas Tenax in Saliva and Subgingival Plaque Samples Among Periodontology Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07551115
- Acronym / sponsor ID
- BAIBU-SBF-BMY-02
- Conditions
- Gingivitis and Periodontal Diseases, Periodontitis
- Keywords
- gingivitis, periodontitis, Entamoeba Gingivalis, Trichomonas Tenax
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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.
- Sample Size and Power Analysis:
The sample size of 120 was determined based on similar prevalence studies in the literature.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontally Healthy | – | Diagnostic Test: Clinical Periodontal Evaluation, Procedure: Microscopic Examination of Oral ProtozoaSystemically healthy individuals with no clinical signs of gingival inflammation (BOP < 10%), no clinical attachment loss, and no probing depths > 3 mm. |
| Gingivitis | – | Diagnostic Test: Clinical Periodontal Evaluation, Procedure: Microscopic Examination of Oral ProtozoaPatients 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. |
| Periodontitis | – | Diagnostic Test: Clinical Periodontal Evaluation, Procedure: Microscopic Examination of Oral ProtozoaPatients diagnosed with periodontitis (stages I-IV) characterized by interdental clinical attachment loss, probing depths ≥ 4 mm, and radiographic evidence of alveolar bone loss. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Periodontal EvaluationComprehensive 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. | Diagnostic test | Gingivitis, Periodontally Healthy, Periodontitis |
| Microscopic Examination of Oral ProtozoaCollection 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. | Procedure or surgery | Gingivitis, Periodontally Healthy, Periodontitis |
Primary outcome
Prevalence of Entamoeba gingivalis and Trichomonas tenax
Time frame: Baseline (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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingivitis and Periodontal Diseases and Periodontitis, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Entamoeba gingivalis and Trichomonas tenax (time frame: Baseline (at the time of clinical examination and sample collection, typically within 1 hour).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.