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

NCT07475195 | Completed

• 1 other identifier: E-25-9941
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Denture Stomatitis; Dentures; Halitosis; Biofilms

Outcome Measures

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

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

  Baseline

Secondary Outcomes (1)

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

  Baseline

Study Arms (2)

Removable partial denture wearers

Patients with removable partial dentures

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

Complete denture wearers

Patients with complete denture

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

Interventions

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.

Complete denture wearers; Removable partial denture wearers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult men and women aged 18 years or older who are currently wearing at least one removable denture (complete or partial) and who received denture treatment at King Saud University Dental Clinics/Dental University Hospital within the past five years. Participants are recruited by convenience sampling from eligible patients identified through the SALUD electronic dental records system.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University

Riyadh, 12786, Saudi Arabia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Retained samples will include denture plaque swab samples, oral mucosal swab samples, and, for partially edentulous participants, periodontal/abutment-site plaque samples. Samples will be stored in sterile Eppendorf tubes with PBS at -80°C for microbiological analysis.

MeSH Terms

Conditions

Stomatitis, Denture; Halitosis

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 16, 2026
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)