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Effect of Probiotics on Oral Candida Among Denture Wearers

Sponsor
Hams Hamed Abdelrahman (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05358743
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
6
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: Probiotic group
  • Other: Placebo group
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Probiotics on Oral Candida Colonization Level in Complete Denture Wearers (Randomized Controlled Clinical Trial)
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

Other: Probiotic group
Participants will use the probiotic product once daily (1 tablet/day) for 8 weeks
Placebo Comparator: Group B

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alexandria Faculty of Dentistry Alexandria Egypt

Sponsors and Collaborators

  • Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University
ClinicalTrials.gov Identifier:
NCT05358743
Other Study ID Numbers:
  • probiotics_2022
First Posted:
May 3, 2022
Last Update Posted:
May 3, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Candidiasis, Oral

Study Results

No Results Posted as of May 3, 2022