Chronic atrophic candidosis or denture stomatitis is the commonest form of oral candidosis. It is an opportunistic infection related to an inflammatory process in the mucosal surface beneath dentures and is a common finding among edentulous patients attending dental schools and those resident in homes for the elderly. The prevalence of this type of candidosis has been increasing with more than 50% of subjects in some studies of elderly denture wearers being reported to have candidosis.
Conditions
Interventions
Product Name: Monocaprin dental paste
Pharmaceutical Form: Dental paste
Product Name: Monocarpin gel
Pharmaceutical Form: Dental gel
Sponsors
Faculty of Odontology, University of Iceland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study will be carried out at the clinic of the Landakot geriatric hospital and the dental clinic of the Faculty of Odontology at the University of Iceland. Subjects will be selected from the group of patients attending the clinic. Patients will be edentulous in the upper jaw and use their dentures routinely. The study will be explained to each individual by the pharmacy students, with supervision and assistance where necessary. Patients must give their informed consent to the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Participants that are cognitively impared will be excluded from the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The applicants have been investigating several new methods for treating common conditions of the oral mucosa. One particular area of interest follows on from the demonstration that monocaprin, a derivative of capric acid, is active against oral yeasts and has, therefore, potential as an alternative treatment for oral yeast infections such as chronic atrophic candidosis or denture stomatitis. The aim of this study is to follow on from the previously-demonstrated in vitro anti-candidal activity into a clinical study by incorporating monocaprin into denture adhesives and mucoadhesive hydrogel. These products will then be tested in clinical trials. It is hoped that these denture products would be improved by imparting anti-candidal activity adjacent to the oral mucosa.;Secondary Objective: Not applicable;Primary end point(s): There will be 60 participants in the study and they will be divided into three groups with 20 participants in each. Group I will receive treatement with dental adhesive containing monocaprin, group II will receive treament with tissue liner containing monocaprin and Group III will be not receive treatment but will function as control. The study will last for four weeks. The participants will be taught how to use the dental adhesive and the mucoadhesive hydrogel and requested to use the monocaprin-containing preparations daily. Speciments will be taken at the beginning of the study, then in two weeks and in four weeks. Speciments will be taken at the beginning of the study, then in two weeks and in four weeks. Specimens will be collected using standard 1sq cm sponges that have been soaked in sterile saline and, using sterile tweezers, placed on i) the fitting surface of the denture; ii) the dorsum of the tongue and iii) the palatal mucosa for about 15 sec. Swabs are then removed and placed on the surface of agar culture plates. Plates will be transferred to the laboratory in the Faculty of Odontology and incubated at 37°C overnig | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Speciments will be taken at the beginning of the study, then in two weeks and in four weeks. ;Timepoint(s) of evaluation of this end point: Two weeks after the termination of treatment with monocaprin containing preparations speciments will be taken to evaluated the extent of re-colonisation. | — |
Countries
Iceland
Contacts
Public ContactW. Peter Holbrook
Faculty of Odontology, University of Iceland
Outcome results
None listed