Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis Comparing to Traditional Treatment of Troches
Condition: Oral Candidiasis; Denture Stomatitis
MeSH terms: Candidiasis; Candidiasis, Oral; Stomatitis; Stomatitis, Denture
Study type: Interventional
Phase: Phase 2

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
    


Intervention name(s): Clotrimazole varnish; Clotrimazole troches
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): Oralten; Oralten
Intervention MeSH terms: Clotrimazole; Miconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oral; candida; denture; clotrimazole; slow releases