Clinical Study New Gel for Xerostomia

Study Overview
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Brief Summary
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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: General measures ; review and control of drugs,hydration and dietary advice: The main recommendations are found in the following scheme. 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 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
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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.

Official Title
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Clinical Study to Evaluate the Efectiveness and Tolerability of a New Gel for Xerostomia

Conditions
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XEROSTOMIA

Intervention / Treatment
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* Drug: gel xerostomia
* Other: gel placebo


Participation Criteria
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Eligibility Criteria
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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: Presence of health problems that may compromise adherence to the study protocol. Pregnant or breastfeeding women. Present hypersensitivity to any component of the product under study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GROUP EXPERIMENTAL<br>Gel 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 | Drug: gel xerostomia<br>* 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<br>* Other names: lubricant and remineralizing agents;|
| Placebo Comparator: CONTROL GROUP<br>Gel 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 | Other: gel placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OHIP 14 | Quality of oral life. minimun 0 maximum 56 points. As it gets higher, quality of life decreases | 1moth | 
| Sialometry | Drenaje | 1moth | 
| Test Thonsom xerostomy | Xerostomia Inventory. the higher the outcome, quality of life decreases | 1moth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry mouth