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

NCT ID: NCT00835029

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-02-29

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

Conditions

Oral Candidiasis; Denture Stomatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clotrimazole varnish

Clotrimazole in a slow release varnish treatment

Group Type: ACTIVE_COMPARATOR

Clotrimazole varnish

Intervention Type: DRUG

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.

Clotrimazole troches

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

Group Type: ACTIVE_COMPARATOR

Clotrimazole troches

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Oralten; Oralten

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Czerninski Rakefet

Dr, Oral diseases clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rakefet Czerninski, DMD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hdassah medical Organization,

Jerusalem, , Israel

Countries

Israel

Other Identifiers

111111

Identifier Type: -

Identifier Source: org_study_id