XEROSTOMIA
Conditions
Keywords
dry mouth
Brief summary
At present, there is no single consensus protocol for the treatment of oral dryness, although the main objective is to improve the quality of life of patients. Current therapy for the control of xerostomia is based on the following measures: 1. General measures ; review and control of drugs,hydration and dietary advice: The main recommendations are found in the following scheme. 2. Saliva stimulants( Topics and sistemic )The option of using chewing stimuli by chewing gum with non-cariogenic sweeteners helps to improve symptoms. The investigators can also use gustatory stimuli, such as citric acid that is a potent stimulator of salivary secretion. Among the most commonly used pharmacological agents are: pilocarpine, bethanecol, civemiline 3. Saliva substitutes or artificial saliva. Saliva substitutes can provide a moisture retention layer in the oral mucosa and can be administered by liquids, spray, pills or gels. Topical treatments have few adverse effects and improve the quality of life of patients with xerostomia; In addition, they maintain oral health.
Detailed description
Randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and tolerability in patients with a non-commercialized gel and property of the promoter to treat xerostomia.
Interventions
DRUGgel xerostomia
Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night
OTHERgel placebo
Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night
Sponsors
Universidad de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects of both sexes 2. Over 18 years. 3. Adequate cultural level and understanding of the clinical study. 4. Agree to voluntarily participate in the study and give their informed consent in writing 5. Present xerostomia of more than three months of evolution / sialometry less than 0.2ml / 5 min.
Exclusion criteria
The presence of at least one of the following criteria will be grounds for exclusion from the clinical trial: 1. Presence of health problems that may compromise adherence to the study protocol. 2. Pregnant or breastfeeding women. 3. Present hypersensitivity to any component of the product under study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OHIP 14 | 1moth | Quality of oral life. minimun 0 maximum 56 points. As it gets higher, quality of life decreases |
| Sialometry | 1moth | Drenaje |
| Test Thonsom xerostomy | 1moth | Xerostomia Inventory. the higher the outcome, quality of life decreases |
Countries
Spain
Contacts
Primary ContactPia López-Jornet, PhD
Outcome results
None listed