- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07551115
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Bilge Meracı Yıldıran, Asst. Prof.
- Phone Number: +905366580192
- Email: bilgemeraci@ibu.edu.tr
Study Locations
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Gölköy
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Bolu, Gölköy, Turkey (Türkiye), 14030
- Recruiting
- Bolu Abant İzzet Baysal University, Faculty of Dentistry, Department of Periodontology
-
Contact:
- Bilge Meracı Yıldıran, Asst. Prof.
- Phone Number: +905366580192
- Email: bilgemeraci@ibu.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Periodontally Healthy
Systemically healthy individuals with no clinical signs of gingival inflammation (BOP < 10%), no clinical attachment loss, and no probing depths > 3 mm.
|
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.
|
|
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.
|
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.
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (at the time of clinical examination and sample collection, typically within 1 hour).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAIBU-SBF-BMY-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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