NCT07551115 Association Between Periodontal Status and the Prevalence of Entamoeba Gingivalis and Trichomonas Tenax
| NCT ID | NCT07551115 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abant Izzet Baysal University |
| Condition | Gingivitis and Periodontal Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-12-22 |
| Primary Completion | 2026-07 |
Trial Parameters
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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.
Eligibility Criteria
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.