Trial document




This trial has been registered retrospectively.
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  DRKS00009368

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

http://n.a.

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Brief Summary in Lay Language

The aim of the study is to evaluate the effectiveness of an additional application of tissue tolerable plasma on certain yeasts (causative agent of oral candidiasis) infected oral mucosa.

Fungal infections of the oral cavity are usually localized infection of the oral mucosa with yeasts of the genus Candida (oral candidiasis). In addition to the presence of pathogens in the oral flora, additional factors, such as coverage of the mucosa by a removable denture (prosthesis) can be given. Apart from asymptomatic infection with e.g. redness and / or benign overgrowth of the mucosa, some patients experience discomfort such as burning of the mouth. The diagnosis is established in a mouth swab, grown on the basis of which any pathogens are identified and quantified. The findings obtained in this way are the basis for subsequent drug antimicrobial therapy. Since it is a biofilm disease in, its destruction has special requirements in the therapy. In addition, removable dentures are a potential germ reservoir. Often, the drug treatment therefore proves to be lengthy. Partial remains a successful treatment, or re-infection (relapse) already occurs after a short time.

The decontamination of affected mucosa including the covering dentures by tissue tolerable cold plasma therefore represents a promising therapeutic approach in addition to drug treatment. During the treatment of chronically infected skin wounds, the method has already been applied successfully.

If it is possible to demonstrate that cold plasma is effective in the treatment of oral candidiasis (faster healing, decrease of symptoms and clinical signs of infection), the procedure for the supportive treatment of oral candidiasis could be established. The therapy could accelerate herewith, and avoid lack of cures and relapses.

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Brief Summary in Scientific Language

The aim of the present pilot study was to investigate the antifungal effect of TTP in patients suffering from denture stomatitis in the upper jaw by applying a double-blind split-mouth design. Placebo treatment was performed on the latter to blind the patient. Nystatin ointment and chlorhexidine mouth wash (CHX) were applied on both sides as a standard level of care. The investigators were different from the clinicians performing therapy and were blinded throughout as well.
Improving the efficacy of oral candidiasis therapy using TTP might reduce the proportion of non-response and recurrent infections and shorten therapy duration. Hereby, remission and relief from complaints could be achieved faster. Furthermore, lavish use of broad-spectrum anti-mycotics could be limited. As a result, selection of innately resistant species as well as resistance acquisition could be avoided to a certain extent.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00009368
  •   2015/09/21
  •   [---]*
  •   yes
  •   Approved
  •   EA2/026/15, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   B37.0 -  Candidal stomatitis
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Interventions/Observational Groups

  •   In clinical routine decontamination of the oral mucosa and prostheses with cold plasma is not performed so far.
    In patients with suspected diagnosis of oral candidiasis in the upper jaw, a microbiological diagnosis is performed (oral swab) on both sides of the upper jaw.
    In addition to the subsequent topical antifungal therapy, which is also carried out according to routine clinical practice, a randomly selected side of the bilateral infected jaw is treated with cold plasma (six-time superficial application (movement of Plasmapen at a speed of 10mm / second)) at intervals of 7 days.
    The corresponding base of the removable denture is also treated with cold plasma as described above. At intervals of one week during the drug treatment, the clinical situation is evaluated in comparing both sides with each other. In addition, photographs are taken to document the course of therapy. Features which allow an identification of the patient (extraoral in the image) are not recognized. Based on the recordings, a computer-aided measurement of erythematous areas is carried out, in order to ensure objectivity. A double blinding is provided here. Users of cold plasma and examiner of the photographs are different people, where the examiner is not known which half of the jaw was treated with cold plasma.The patient does not know which side was treated either, since the retraction of the oral mucosa is also on the control side in OFF mode.
    If prior to the conclusion of the six-week application, plasma already lead to a total remission on the test side, no further plasma decontamination is performed.
  •   The latter side of the upper jaw was not treated with TTP, but a placebo treatment was performed.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor, data analyst
  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/03/11
  •   8
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   95   Years
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Additional 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.

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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.

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Addresses

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    • Charité Campus Benjamin Franklin
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Charité Campus Benjamin Franklin; CC3 - Zahn-, Mund- und Kieferheilkunde
    • Ms.  PD Dr.  Saskia  Preissner 
    • Assmannshauser Str. 4-6
    • 14197  Berlin
    • Germany
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    • Charité Campus Benjamin Franklin; CC3 - Zahn-, Mund- und Kieferheilkunde
    • Ms.  PD Dr.  Saskia  Preissner 
    • Assmannshauser Str. 4-6
    • 14197  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/08/05
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.