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

February 1, 2009
June 22, 2011
March 2009
December 2011   (final data collection date for primary outcome measure)
Microbial evidence of reduced candida infection [ Time Frame: one and two weeks after inevention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00835029 on ClinicalTrials.gov Archive Site
Clinical evidence for candida infection [ Time Frame: One and two weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis Comparing to Traditional Treatment of Troches
Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Oral Candidiasis
  • Denture Stomatitis
  • 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
  • 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
  • Active Comparator: Clotrimazole varnish
    Clotrimazole in a slow release varnish treatment
    Intervention: Drug: Clotrimazole varnish
  • Active Comparator: Clotrimazole troches
    Clotrimazole troches 10 mgx5 day for treatment of denture associated candiad infection
    Intervention: Drug: Clotrimazole troches
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
March 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00835029
111111
No
Dr.Rakefet Czerninski, : Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Principal Investigator: Rakefet Czerninski, DMD Hadassah Medical Center
Hadassah Medical Organization
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP