A Stimulator of the Salivary Vibration of the Parotid Glands

Study Overview
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Brief Summary
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Oral dryness causes significant health problems both functional (difficulty speaking, chewing and swallowing) and structural problems in teeth (increased number of infections) and oral mucosa. The main objective of this study is to show an alternative treatment to help to stimulate the salivary secretion thus improving the quality of life of the patient. In this study, a salivary stimulation equipment using vibrotactile stimuli is shown. The system has been placed bilaterally in the parotid glands and assessed the efficacy of the salivary secretion by sialometry before and after the stimulation. The new proposal is capable of stimulating salivary secretion, in a significative way after 7 minutes of use, at least in the cases analyzed, and fulfills low-cost, easy-to-use and safe technical restrictions. In this setting, this paper suggests the performance of a deep clinical trial to measure the exact efficacy of the prototype and the times and frequencies needed to state the optimal treatment depending in each case

Official Title
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A Stimulator of the Salivary Excretion Based on Physical Vibration of the Parotid Glands.

Conditions
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Saliva Stimulated

Intervention / Treatment
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* Device: PHYSICAL VIBRATION OF THE PAROTID GLANDS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sialometria <01,mL /5 min Test Thomson Exclusion Criteria: Not signing informed consent Bad medical status

Ages Eligible for Study
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Minimum Age: 18 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: Single Group Assignment
Interventional Model Description: The central idea of the device resides in transmitting the vibration generated by two vibrating modules to the two parotid glands through the superficial contact established between each vibrating module and the respective parotid gland, achieving the stimulation of both parotid glands simultaneously.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: STIMULATOR OF THE SALIVARY EXCRETION BASED ON PHYSICAL VIBRATION<br>Measurement of salivary secretion at rest and stimulated conditions. | Device: PHYSICAL VIBRATION OF THE PAROTID GLANDS<br>* The system will be placed bilaterally in the parotid glands and assessed the efficacy of the salivary secretion by sialometry before and after the stimulation<br>|
| Placebo Comparator: STIMULATOR OF THE SALIVARY EXCRETION PLACEBO<br>Measurement of salivary secretion at rest and stimulated conditions. | Device: PHYSICAL VIBRATION OF THE PAROTID GLANDS<br>* The system will be placed bilaterally in the parotid glands and assessed the efficacy of the salivary secretion by sialometry before and after the stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sialometry | The test we will use consists of measuring the amount of saliva produced during a period of 5 mins when a millimetre strip of paper with a dimension of 1 cm wide and 17 cm is applied. | up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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saliva