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临床试验/NCT07475195
NCT07475195已完成不适用

Oral Probiotics and Denture Care in Saudi Arabia: Evaluating Knowledge, Practices, and the Future of Innovative Hygiene Solutions

King Saud University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Knowledge, awareness, and self-reported hygiene practices related to denture hygiene and oral probiotics among adult denture wearers, assessed using a validated questionnaire

研究概览

简要总结

The goal of this observational study is to learn about denture wearers' knowledge, awareness, and self-reported practices regarding denture hygiene and oral probiotics, and to assess whether these are associated with clinical oral findings and microbial colonization in adult denture wearers (18 years and older), including complete and partial denture users treated at King Saud University Dental Clinics within the past five years. The main questions it aims to answer are:

What are the levels of knowledge, awareness, and practices related to denture hygiene and oral probiotics among adult denture wearers?

What is the prevalence of denture-related oral conditions and bacterial/fungal colonization, and how are these related to denture hygiene knowledge and self-reported hygiene practices?

Participants will:

Complete an electronic questionnaire in Arabic or English about demographics, denture hygiene knowledge, awareness of oral probiotics, and current denture care practices.

Attend a 15-20 minute clinical visit for examination of dentures and oral mucosa.

Be asked to avoid cleaning their denture for at least 12 hours before the visit.

Undergo plaque sample collection from dentures and oral tissues; partially edentulous participants will also have additional samples collected from abutment areas.

Have samples analyzed using real-time PCR and culture methods (CFU) to detect bacterial and fungal microorganisms.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Adults 18 years or older
  • Currently wearing at least one removable denture (complete or partial)
  • Denture received/used within the past five years
  • Willing and able to provide informed consent

排除标准

  • Severe systemic conditions affecting oral health, such as:
  • Uncontrolled diabetes (HbA1c > 7) and Immunosuppression
  • Breastfeeding
  • Cognitive or physical impairment that limits the ability to perform routine oral and denture care practices

研究组 & 干预措施

Removable partial denture wearers

Patients with removable partial dentures

干预措施: This is a cross-sectional observational study. Participants are not assigned to any treatment or preventive intervention. (Other)

Complete denture wearers

Patients with complete denture

干预措施: This is a cross-sectional observational study. Participants are not assigned to any treatment or preventive intervention. (Other)

结局指标

主要结局

Knowledge, awareness, and self-reported hygiene practices related to denture hygiene and oral probiotics among adult denture wearers, assessed using a validated questionnaire

时间窗: Baseline

Knowledge, awareness, and self-reported hygiene practices related to denture hygiene and oral probiotics among adult denture wearers, assessed using a validated questionnaire

次要结局

  • Prevalence of denture-related oral complications and bacterial/fungal colonization, assessed through clinical examination, culture (CFU), and real-time PCR(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

yasser fahad alrayyes

Clinical Professor

King Saud University

研究点 (1)

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