Adjuvant Antifungal Therapy Using Tissue Tolerable Plasma on Oral Mucosa and Removable Dentures in Oral Candidiasis Patients: A Double-Blinded Split-Mouth Pilot Study.

Not Applicable

• Conditions: B37.0; Candidal stomatitis

• Registration Number: DRKS00009368
• Lead Sponsor: Charité Campus Benjamin Franklin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-08-05
• Study Start: 2015-09-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Patients eligible for inclusion were able to give informed consent, were between 18 and 95 years old and non-smokers (for =5 years). All patients wore removable prostheses, partially or totally covering the upper alveolar ridge and/or hard palate. Confirmation of diagnosis assumed from clinical signs of infection (at least in terms of erythematous maculae or zones but possibly hyperplasia or complaints as well) via Candida detection was required. Hence, all subjects were diagnosed with denture stomatitis Newton-level 1, 2 or 3 based on both positive clinical and paraclinical findings.

Exclusion Criteria

Patients having suffered from any malignant tumor within the last five years or suffering from severe general diseases (American Society of Anesthesiologists (ASA) risk class = 3, myocardial infarction within the last six months, cardiomyopathy, New York Heart Association (NYHA) cardiac insufficiency stage = III, chronic obstructive pulmonary disease (COPD), renal insufficiency, diabetes mellitus (HbA1c = 7%), sickle-cell anemia, rheumatoid arthritis, status post radiation or organ transplantation, malnutrition) were excluded from the study. Furthermore, pacemaker carriers, pregnant women, smokers, alcoholics and drug users were not eligible.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
At the end of treatment after six-time plasma application there is a remission of erythema. The evaluation is carried out using a digital measurement of the photographs made.

Secondary Outcome Measures

Name	Time	Method
At the end of treatment after six-time plasma application Candida spp. can not or only sporadically be detected. A mouth swab confirms this. There is a reduction in VAS scores in cases with existing complaints. These are collected once a week.