Prevalence of Entamoeba Gingivalis and Trichomonas Tenax in Saliva and Subgingival Plaque Samples Among Periodontology Patients: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Prevalence of Entamoeba gingivalis and Trichomonas tenax
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Periodontally Healthy
Systemically healthy individuals with no clinical signs of gingival inflammation (BOP < 10%), no clinical attachment loss, and no probing depths > 3 mm.
干预措施: Clinical Periodontal Evaluation (Diagnostic Test)
Periodontally Healthy
Systemically healthy individuals with no clinical signs of gingival inflammation (BOP < 10%), no clinical attachment loss, and no probing depths > 3 mm.
干预措施: Microscopic Examination of Oral Protozoa (Procedure)
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.
干预措施: Clinical Periodontal Evaluation (Diagnostic Test)
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.
干预措施: Microscopic Examination of Oral Protozoa (Procedure)
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.
干预措施: Clinical Periodontal Evaluation (Diagnostic Test)
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.
干预措施: Microscopic Examination of Oral Protozoa (Procedure)
结局指标
主要结局
Prevalence of Entamoeba gingivalis and Trichomonas tenax
时间窗: 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.
次要结局
未报告次要终点
研究者
Bilge MERACI YILDIRAN
Assistant Professor
Abant Izzet Baysal University