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Effect of Probiotics on Oral Candida Among Denture Wearers

H

Hams Hamed Abdelrahman

Status

Active, not recruiting

Conditions

Oral Candida Albicans Infection

Treatments

Other: Probiotic group
Other: Placebo group

Study type

Interventional

Funder types

Other

Identifiers

NCT05358743
probiotics_2022

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups, including a placebo group

Probiotic group
Experimental group
Treatment:
Other: Probiotic group
Control group
Placebo Comparator group
Treatment:
Other: Placebo group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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