Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis Comparing to Traditional Treatment of Troches
Information source: Hadassah Medical Organization
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Oral Candidiasis; Denture Stomatitis
Intervention: clotrimazole ,slow release varnish (Drug); clotrimazole (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Hadassah Medical Organization Official(s) and/or principal investigator(s):
Rakefet Czerninski, DMD, Principal Investigator, Affiliation: Hadassah Medical Center
Overall contact:
Rakefet Czerninski, DMD, Phone: 01197226776140, Email: rakefetc@hadassah.org.il
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
Clinical Details
Official title: Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Microbial evidence of reduced candida infection
Secondary outcome: Clinical evidence for candida infection
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Rakefet Czerninski, DMD, Phone: 01197226776140, Email: rakefetc@hadassah.org.il
Hdassah medical Organization,, Jerusalem, Israel
Additional Information
Starting date: March 2009
Last updated: February 2, 2009
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