Denture StomatitisNCT07475195
Oral Probiotics and Denture Care in Saudi Arabia: Evaluating Knowledge, Practices, and the Future of Innovative Hygiene Solutions
An observational study of Denture Stomatitis and Dentures, run by King Saud University at 1 site in Saudi Arabia.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Denture Stomatitis, Dentures, Halitosis
- What is being tested?
- This is a cross-sectional observational study. Participants are not assigned to any treatment or preventive intervention.
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2025to 1 Mar 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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
- Being tested
- This is a cross-sectional observational study. Participants are not assigned to any treatment or preventive intervention.
- Medical subject headings
- Stomatitis, Denture, Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Removable partial denture wearers | Patients with removable partial dentures Receives: 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 Receives: Other: This is a cross-sectional observational study. Participants are not assigned to any treatment or preventive intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Sep 2025
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denture StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yasser fahad alrayyes, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475195
- Sponsor's protocol ID
- E-25-9941
- Status last verified
- Aug 2025
- First submitted
- 8 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Probiotics and Denture Care in Saudi Arabia: Evaluating Knowledge, Practices, and the Future of Innovative Hygiene Solutions
- ClinicalTrials.gov ID
- NCT07475195
- Acronym / sponsor ID
- E-25-9941
- Conditions
- Denture Stomatitis, Dentures, Halitosis, Biofilms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Removable partial denture wearers | – | Other: This is a cross-sectional observational study. Participants are not assigned to any treatment or preventive intervention.Patients with removable partial dentures |
| Complete denture wearers | – | Other: This is a cross-sectional observational study. Participants are not assigned to any treatment or preventive intervention.Patients with complete denture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Uncontrolled diabetes (HbA1c > 7) and Immunosuppression
- Pregnancy
- Breastfeeding
- Cognitive or physical impairment that limits the ability to perform routine oral and denture care practices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This 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. | Other | Complete denture wearers, Removable partial denture wearers |
Primary outcome
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
1 secondary outcome
Prevalence of denture-related oral complications and bacterial/fungal colonization, assessed through clinical examination, culture (CFU), and real-time PCR
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Denture Stomatitis
Not yet recruiting
Development of a Sanitizing Tablet for Removable Partial Dentures
Denture Stomatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Denture Stomatitis and Dentures, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.