Effect of Probiotics on Oral Candida Among Denture Wearers

Not Applicable

Active, not recruiting

• Conditions: Oral Candida Albicans Infection
• Interventions: Other: Placebo group; Other: Probiotic group

• Registration Number: NCT05358743
• Lead Sponsor: Hams Hamed Abdelrahman

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-28
• Study First Submitted QC: 2022-04-28
• Study Start: 2022-05-01
• Study First Posted: 2022-05-03
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12
• Primary Completion: 2023-01-30
• Study Completion: 2023-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo group	-
Probiotic group	Probiotic group	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt