- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Riyadh, Saudi Arabia, 12786
- King Saud University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Removable partial denture wearers
Patients with removable partial dentures
|
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
Patients with complete denture
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-25-9941
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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