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Effect of Probiotics on Oral Candida Among Denture Wearers

Primary Purpose

Oral Candida Albicans Infection

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Probiotic group
Placebo group
Sponsored by
Hams Hamed Abdelrahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Candida Albicans Infection

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Alexandria Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic group

Control group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 28, 2022
Last Updated
January 11, 2023
Sponsor
Hams Hamed Abdelrahman
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1. Study Identification

Unique Protocol Identification Number
NCT05358743
Brief Title
Effect of Probiotics on Oral Candida Among Denture Wearers
Official Title
Effect of Probiotics on Oral Candida Colonization Level in Complete Denture Wearers (Randomized Controlled Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Candida Albicans Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Probiotic group
Intervention Description
Participants will use the probiotic product once daily (1 tablet/day) for 8 weeks
Intervention Type
Other
Intervention Name(s)
Placebo group
Intervention Description
Patients will chew placebo products (blueberry tablets) once daily (1 tablet/day) for 8 weeks.
Primary Outcome Measure Information:
Title
Change in candida count
Description
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.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Alexandria Faculty of Dentistry
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

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Effect of Probiotics on Oral Candida Among Denture Wearers

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