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OpenTrials
Completed

NCT Number: NCT07475195

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King Saud University

Riyadh, 12786, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Severe systemic conditions affecting oral health, such as:

Uncontrolled diabetes (HbA1c > 7) and Immunosuppression

Pregnancy

Breastfeeding

Cognitive or physical impairment that limits the ability to perform routine oral and denture care practices

Treatment and study plan

This is a cross-sectional observational study. Participants are not assigned to any treatment or preventive intervention.

Other

This is a cross-sectional observational study. Participants are not assigned to any treatment or preventive intervention. They will only undergo questionnaire completion, clinical examination, and noninvasive plaque and mucosal sample collection.

Primary outcomes

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

    Time frame: Baseline

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

Secondary outcomes

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

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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