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Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis Comparing to Traditional Treatment of Troches

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00835029
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : March 25, 2015
Information provided by (Responsible Party):
Czerninski Rakefet, Hadassah Medical Organization

Brief Summary:

Background: Oral candidiasis is most frequently found among the elderly .It is accompanied with oral pain, irritation, burning sensation. In addition, the altered taste sensation may cause nutrition compromise, which may affect ones diet. Management of superficial oral Candida is usually achieved by treatment with clotrimazole, a fungi static drug which is given five times per day with instruction to slowly suck on it with out the dentures.

Working hypothesis and aims: Management of oral candidiasis is feasible. The major disadvantage of the mode of action now days is the substantively of the drug in the oral cavity and patient compliance. A sustained release varnish which is easily applied on the dentures, which also release the anti fungal drug for at least a day, may overcome some of the pit falls of the treatment applied today.

Based on our past experience, in developing local sustained release varnishes for dental use, we anticipate that we can also formulate a special anti fungal sustained release varnish which will fit the special and unique needs of the elderly population.

Methods: Sustained release varnish will be developed in our laboratory. The kinetics of release (using HPLC) and antifungal activity (Bioassays) will be examined in vitro. The formulation showing the optimal results will be tested on human subjects with oral candidiasis. The efficacy of the varnish will be examined clinically (reduction in symptoms), microbiology (reduction of oral fungal), pharmaceutically (release kinetics in vivo).

Expected results: The clinical out come of one time varnish application will be improved compared to the five times application of lozenges (used today). The severity of the disease should decrease and the healing period should be shorten drastically.

Importance: This is a novel pharmaceutical development of a local application of a dental varnish designed specially to the elderly population

Condition or disease Intervention/treatment Phase
Oral Candidiasis Denture Stomatitis Drug: Clotrimazole varnish Drug: Clotrimazole troches Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis
Study Start Date : March 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Clotrimazole varnish
Clotrimazole in a slow release varnish treatment
Drug: Clotrimazole varnish
Each patient will receive 14 syringes (with no needle, equivalent to 50 mg of Clotrimazole in each one) . The varnish will be applied on a dried denture at the inner side by means of a soft brush and left to dry for 60 sec for 14 days.
Other Name: Oralten

Active Comparator: Clotrimazole troches
Clotrimazole troches 10 mgx5 day for treatment of denture associated candiad infection
Drug: Clotrimazole troches
The troche group will be asked to dissolve it in the mouth according to the manufacture instructions five times a day after removal of the denture, for 14 days.
Other Name: Oralten

Primary Outcome Measures :
  1. Microbial evidence of reduced candida infection [ Time Frame: one and two weeks after inevention ]

Secondary Outcome Measures :
  1. Clinical evidence for candida infection [ Time Frame: One and two weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adults
  • removable denture in mouth
  • diagnosed oral candida

Exclusion Criteria:

  • allergy to clotrimazole
  • immunosuppressed
  • using other antifungi treatment
  • have an active oral ulcerative disease
  • impaired kidny or live functions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00835029

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Hdassah medical Organization,
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Rakefet Czerninski, DMD Hadassah Medical Center
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Responsible Party: Czerninski Rakefet, Dr, Oral diseases clinic, Hadassah Medical Organization Identifier: NCT00835029    
Other Study ID Numbers: 111111
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015
Keywords provided by Czerninski Rakefet, Hadassah Medical Organization:
slow releases
Additional relevant MeSH terms:
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Candidiasis, Oral
Stomatitis, Denture
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Antifungal Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors