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

Denture Stomatitis Clinical Trial

Official title:

Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835029
• Other study ID #: 111111
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2009
• Last updated: March 24, 2015
• Start date: March 2009
• Est. completion date: February 2012

Study information

• Verified date: March 2015
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral
• Denture Stomatitis
• Oral Candidiasis
• Stomatitis
• Stomatitis, Denture

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Hdassah medical Organization,	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbial evidence of reduced candida infection		one and two weeks after inevention	No
Secondary	Clinical evidence for candida infection		One and two weeks	No