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

Study Overview
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Brief Summary
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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

Official Title
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Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis

Conditions
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Oral Candidiasis, Denture Stomatitis

Intervention / Treatment
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* Drug: Clotrimazole varnish
* Drug: Clotrimazole troches


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clotrimazole varnish<br>Clotrimazole in a slow release varnish treatment | Drug: Clotrimazole varnish<br>* 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.<br>* Other names: Oralten;|
| Active Comparator: Clotrimazole troches<br>Clotrimazole troches 10 mgx5 day for treatment of denture associated candiad infection | Drug: Clotrimazole troches<br>* 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.<br>* Other names: Oralten;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial evidence of reduced candida infection |  | one and two weeks after inevention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evidence for candida infection |  | One and two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral, candida, denture, clotrimazole, slow releases