Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis Comparing to Traditional Treatment of Troches
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Oral Candidiasis Denture Stomatitis |
Drug: Clotrimazole varnish Drug: Clotrimazole troches |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis |
- Microbial evidence of reduced candida infection [ Time Frame: one and two weeks after inevention ] [ Designated as safety issue: No ]
- Clinical evidence for candida infection [ Time Frame: One and two weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr.Rakefet Czerninski, : Hadassah Medical Organization |
| ClinicalTrials.gov Identifier: | NCT00835029 History of Changes |
| Other Study ID Numbers: | 111111 |
| Study First Received: | February 1, 2009 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Hadassah Medical Organization:
|
oral candida denture clotrimazole slow releases |
Additional relevant MeSH terms:
|
Candidiasis Candidiasis, Oral Stomatitis Stomatitis, Denture Mycoses Mouth Diseases Stomatognathic Diseases Clotrimazole Miconazole |
Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antifungal Agents |
ClinicalTrials.gov processed this record on May 21, 2013