Clinical trial NCT00835029: Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis Comparing to Traditional Treatment of Troches
Official title: Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Candidiasis
Denture Stomatitis
Keywords: oral
candida
denture
clotrimazole
slow releases
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-02-03
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Microbial evidence of reduced candida infection
timeFrame: one and two weeks after inevention
Secondary outcomes:
measure: Clinical evidence for candida infection
timeFrame: One and two weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hdassah medical Organization,
Study officials:
affiliation: Hadassah Medical Organization
name: Rakefet Czerninski, DMD
role: PRINCIPAL_INVESTIGATOR
References: