Effect of Probiotics on Oral Candida Among Denture Wearers
1 other identifier
interventional
50
1 country
1
Brief Summary
Forty-eight denture wearers with detectable levels of candida colonization without clinical symptoms will be randomly allocated into two groups: probiotics and placebo. All patients will take a daily dose of chewable tablets (probiotics or placebo according to the assigned group) for 8 weeks. Samples of mouth rinse will be collected from patients at baseline, 4 weeks from the beginning of the intervention, 8 weeks (the end of intervention), and after another 4 weeks for post-intervention follow up. Samples will be tested for both candida count and candida species identification
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedFirst Posted
Study publicly available on registry
May 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2023
CompletedJanuary 12, 2023
January 1, 2023
9 months
April 28, 2022
January 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in candida count
Quantitative culture will be performed from mouth-rinse samples by inoculation onto the surface of Sabouraud dextrose agar plates with chloramphenicol, and subsequent aerobic incubation for 24 to 48 hours at 37°C.
Baseline, 4 weeks, 8 weeks, 12 weeks
Study Arms (2)
Probiotic group
EXPERIMENTALControl group
PLACEBO COMPARATORInterventions
Participants will use the probiotic product once daily (1 tablet/day) for 8 weeks
Patients will chew placebo products (blueberry tablets) once daily (1 tablet/day) for 8 weeks.
Eligibility Criteria
You may qualify if:
- Detectable levels of Candida in palatal mucosa without clinical symptoms of active candidiasis.
- Completely edentulous arches with newly formed denture .
- Patients with controlled hypertension, and diabetes will be included in this study as they are considered very common problems in the targeted population.
You may not qualify if:
- Inability to understand/ follow the experimental procedures,
- Administration of topic or systemic antifungal or antibacterial agents in the previous 60 days.
- Consumption of probiotics.
- GITdisorders.
- Heartdisease.
- Diseases that significantly influence immunity such as; kidney problems, head and neck cancer, or radiotherapy, AIDS, or immunosuppressive therapy.
- Clinical manifestations of oral candidiasis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alexandria Faculty of Dentistry
Alexandria, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer of DPH and Clinical statistician
Study Record Dates
First Submitted
April 28, 2022
First Posted
May 3, 2022
Study Start
May 1, 2022
Primary Completion
January 30, 2023
Study Completion
January 30, 2023
Last Updated
January 12, 2023
Record last verified: 2023-01