Effect of Probiotics on Oral Candida Among Denture Wearers

NCT ID: NCT05358743

Last Updated: 2023-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-01-30

Brief Summary

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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

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Conditions

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Oral Candida Albicans Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Probiotic group

Group Type EXPERIMENTAL

Probiotic group

Intervention Type OTHER

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

Control group

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type OTHER

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

Interventions

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Probiotic group

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

Intervention Type OTHER

Placebo group

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

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Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Alexandria Faculty of Dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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probiotics_2022

Identifier Type: -

Identifier Source: org_study_id

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