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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00835029
First received: February 1, 2009
Last updated: June 22, 2011
Last verified: June 2011
  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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Microbial evidence of reduced candida infection [ Time Frame: one and two weeks after inevention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835029

Locations
Israel
Hdassah medical Organization,
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Rakefet Czerninski, DMD Hadassah Medical Center
  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 April 16, 2014