monddroogte oral dryness xerostomia
Conditions
Interventions
Use of a mouthspray for the relieve of a dry mouth and a placebo without active
ingrediënt. Both products will be used for two weeks, in random order
Sponsors
Academisch Centrum Tandheelkunde Amsterdam (ACTA)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Male or female, over 18 years of age, and capable of providing their written informed consent. * An unstimulated whole mouth salivary flow
Exclusion criteria
Exclusion criteria: * Patients currently using a potassium-sparing diuretic antihypertensive drug that contains amiloride; spironolactone (e.g.,Aldactone, Novo-Spiroton, Spiractin, Spirtone, Verospiron or Berlactone); triamterene (e.g., Dyrenium); or plerenone (e.g., Inspra). Chronic use of antihistamines will be permitted if started at least 30 days before the start of the trial, and a stable dose is maintained throughout the trial. * Patients who started using systemic cholinergic secretagogues or tricyclic antidepressant drugs within 12 weeks before screening, patients who are not on a stable dosing regimen for at least 14 days prior to the screening visit, or patients who are unable to maintain stable dosing throughout the study. * Females who are pregnant or trying to become pregnant, or are nursing. * Patients showing evidence of a significant active or ongoing oral infection or other oral conditions (eg, lichen planus) that, in the opinion of the Investigator, might affect the safety of the subject or be exacerbated during study participation. * Patients suffering from acute infections of the salivary glands. * Patients with a present history of any clinically significant and uncontrolled neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, or hematological disorder or disease, or any other major disorder or disease, in the opinion of the Investigator. * Patients consuming more than 2 alcoholic drinks per day or with a significant history of alcoholism or drug/chemical abuse within the past 12 months. * Patients who have received an investigational drug within the past 30 days. * Patients with a history of allergy to chicken egg proteins or food preservatives * Patients having an unstimulated whole mouth salivary flow > 0.20 ml/min. * Patients who are incapable of filling out questionnaires because of cognitive or physical inability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter measured is the evaluation of the alleviation of dryness of the mouth after use of the product, compared to the placebo. This will be measured using questionnaires | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are: The appreciation of the product by the volunteers, using a questionnaire The unstimulated salivary flow rate before and after the use of both products. | — |
Countries
Netherlands
Outcome results
None listed