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CompletedNCT07475195Updated Mar 16, 2026

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

An observational study in Denture Stomatitis, Dentures and Halitosis, sponsored by King Saud University. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by King Saud University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Denture Stomatitis
  • Dentures
  • Halitosis
  • Biofilms
03

In context

Stomatitis, Denture

21 studies on the registry are indexed under Stomatitis, Denture; 1 is open to participants now.

Browse Stomatitis, Denture studies →

Lead sponsor

King Saud University is the lead sponsor of 169 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

Severe systemic conditions affecting oral health, such as:

Uncontrolled diabetes ( > 7) and

Pregnancy

Breastfeeding

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

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
100 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

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

    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.

06

What researchers measure

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

    Time frame: Baseline

Secondary outcomes

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

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

    Time frame: Baseline

07

Study locations

1 site
  • King Saud University
    Riyadh, 12786, Saudi Arabia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2025 to primary completion in Mar 2026, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 8, 2026
First posted
Mar 16, 2026
StartActual
Sep 1, 2025
Primary completionActual
Mar 1, 2026
CompletionActual
Mar 1, 2026
Last update
Mar 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07475195
Responsible party
yasser fahad alrayyes (Clinical Professor, King Saud University) — Principal investigator
First posted
Mar 16, 2026
Start date
Sep 1, 2025
Primary completion
Mar 1, 2026
Completion
Mar 1, 2026
Last update
Mar 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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