Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis Comparing to Traditional Treatment of Troches
Primary Purpose
Oral Candidiasis, Denture Stomatitis
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Clotrimazole varnish
Clotrimazole troches
Sponsored by
About this trial
This is an interventional treatment trial for Oral Candidiasis focused on measuring oral, candida, denture, clotrimazole, slow releases
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
Sites / Locations
- Hdassah medical Organization,
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Clotrimazole varnish
Clotrimazole troches
Arm Description
Clotrimazole in a slow release varnish treatment
Clotrimazole troches 10 mgx5 day for treatment of denture associated candiad infection
Outcomes
Primary Outcome Measures
Microbial evidence of reduced candida infection
Secondary Outcome Measures
Clinical evidence for candida infection
Full Information
NCT ID
NCT00835029
First Posted
February 1, 2009
Last Updated
March 24, 2015
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00835029
Brief Title
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
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Candidiasis, Denture Stomatitis
Keywords
oral, candida, denture, clotrimazole, slow releases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clotrimazole varnish
Arm Type
Active Comparator
Arm Description
Clotrimazole in a slow release varnish treatment
Arm Title
Clotrimazole troches
Arm Type
Active Comparator
Arm Description
Clotrimazole troches 10 mgx5 day for treatment of denture associated candiad infection
Intervention Type
Drug
Intervention Name(s)
Clotrimazole varnish
Other Intervention Name(s)
Oralten
Intervention Description
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
Intervention Name(s)
Clotrimazole troches
Other Intervention Name(s)
Oralten
Intervention Description
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.
Primary Outcome Measure Information:
Title
Microbial evidence of reduced candida infection
Time Frame
one and two weeks after inevention
Secondary Outcome Measure Information:
Title
Clinical evidence for candida infection
Time Frame
One and two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakefet Czerninski, DMD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hdassah medical Organization,
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis Comparing to Traditional Treatment of Troches
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