|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Hadassah Medical Organization |
|---|---|
| Information provided by: | Hadassah Medical Organization |
| ClinicalTrials.gov Identifier: | NCT00835029 |
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 ,slow release varnish Drug: clotrimazole |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis |
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Clotrimazole in a slow release varnish treatment
|
Drug: clotrimazole ,slow release varnish
clotrimazole,50 mg ,in a slow release varnish formulation for local application on the denture
|
|
2: Active Comparator
Clotrimazole troches 10 mgx5 day for treatment of denture associated candiad infection
|
Drug: clotrimazole
clotrimazole troches 10 mgx5 a day for two weeks arm 1
|
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Rakefet Czerninski, DMD | 01197226776140 | rakefetc@hadassah.org.il |
| Contact: Rakefet Czerninski, DMD | 01197226776151 | eran02@bezeqint.net |
| Israel | |
| Hdassah medical Organization, | |
| Jerusalem, Israel | |
| Principal Investigator: | Rakefet Czerninski, DMD | Hadassah Medical Center |
More Information
| Responsible Party: | : Hadassah Medical Organization ( Dr.Rakefet Czerninski ) |
| Study ID Numbers: | 111111 |
| Study First Received: | February 1, 2009 |
| Last Updated: | February 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00835029 History of Changes |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
|
oral candida denture clotrimazole slow releases |
|
Mouth Diseases Anti-Infective Agents Candidiasis, Oral Candidiasis Stomatitis Clotrimazole Miconazole |
Stomatitis, Denture Pharmacologic Actions Mycoses Anti-Infective Agents, Local Antifungal Agents Therapeutic Uses Stomatognathic Diseases |