CelAgace™ OraRinse for Oral Thrush

Overseen By Celeste M. Abraham, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: CelaCare Technologies, Inc.

Must not be taking: Antifungals

Disqualifiers: Under 18, Pregnant, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

CelAgace™ OraRinse (silver citrate complex and acemannan) Solution is planned to be evaluated for safety and effectiveness as a potential treatment for candidiasis, a yeast infection, commonly known as thrush, which is associated with mouth sores.

Research Team

Jacqueline M. Plemons, DDS, MS

Principal Investigator

Texas A&M University College of Dentistry

Eligibility Criteria

This trial is for adults with mild to moderate oral thrush due to immunocompromise or treatments like chemotherapy. It's not for pregnant/breastfeeding individuals, those who can't use an oral rinse, have a history of oral cancer, used antifungals recently, are allergic to Aloe Vera/Silver, wear removable dental appliances, or have severe mouth sores.

Inclusion Criteria

I have a fungal mouth infection due to radiation treatment.

I have mouth sores with a yeast infection.

I have a mouth infection caused by yeast after chemotherapy.

Exclusion Criteria

Hypersensitivity to Aloe Vera and/or Silver

Candida rinse culture performed greater than 10 days prior to study entry

Any sort of removable dental appliance

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants will swish and spit the product 4 times daily for 14 days

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• CelAgace™ OraRinse Solution

Trial Overview The trial tests CelAgace™ OraRinse Solution containing silver citrate complex and acemannan for treating candidiasis (oral thrush). The goal is to see if it's safe and effective in healing mouth sores associated with yeast infections.

Participant Groups

Group I: silver citrate complex and acemannan Experimental Treatment 1 Intervention

This is a single arm open pilot trial. All participants will receive study drug.

Who Is Running the Clinical Trial?

CelaCare Technologies, Inc.

Lead Sponsor

Trials

1

Recruited

20+

Texas A&M University

Collaborator

Trials

156

Recruited

28,900+