Effect of Probiotics on Oral Candida Among Denture Wearers

Effect of Probiotics on Oral Candida Colonization Level in Complete Denture Wearers (Randomized Controlled Clinical Trial)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05358743

Enrollment

Registered

2022-05-03

Start date

2022-05-01

Completion date

2023-01-30

Last updated

2023-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Candida Albicans Infection

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

Interventions

OTHERProbiotic group

Participants will use the probiotic product once daily (1 tablet/day) for 8 weeks

OTHERPlacebo group

Patients will chew placebo products (blueberry tablets) once daily (1 tablet/day) for 8 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Change in candida count	Baseline, 4 weeks, 8 weeks, 12 weeks	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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026