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

Hadassah Medical Center

Status and phase: Completed; Phase 2

Conditions: Oral Candidiasis; Denture Stomatitis

Treatments: Drug: Clotrimazole troches; Drug: Clotrimazole varnish

Study type: Interventional

Funder types: Other

Identifiers

NCT00835029

111111

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Clotrimazole varnish

Active Comparator group

Description:

Clotrimazole in a slow release varnish treatment

Treatment:

Drug: Clotrimazole varnish

Clotrimazole troches

Active Comparator group

Description:

Clotrimazole troches 10 mgx5 day for treatment of denture associated candiad infection

Treatment:

Drug: Clotrimazole troches