A Stimulator of the Salivary Vibration of the Parotid Glands

Not Applicable

Completed

• Conditions: Saliva Stimulated
• Interventions: Device: PHYSICAL VIBRATION OF THE PAROTID GLANDS

• Registration Number: NCT05129111
• Lead Sponsor: Universidad de Murcia

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-12
• Primary Completion: 2021-07-03
• Study Completion: 2021-09-01
• Status Verified: 2021-11
• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-11-22
• Last Update Submitted: 2021-11-22
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Sialometria <01,mL /5 min
• Test Thomson

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Exclusion Criteria

• Not signing informed consent
• Bad medical status

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STIMULATOR OF THE SALIVARY EXCRETION BASED ON PHYSICAL VIBRATION	PHYSICAL VIBRATION OF THE PAROTID GLANDS	Measurement of salivary secretion at rest and stimulated conditions.
STIMULATOR OF THE SALIVARY EXCRETION PLACEBO	PHYSICAL VIBRATION OF THE PAROTID GLANDS	Measurement of salivary secretion at rest and stimulated conditions.

Primary Outcome Measures

Name	Time	Method
sialometry	up to 4 weeks	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.

Trial Locations

Locations (1)

Lopez-Jornet Pia; 🇪🇸 Murcia, N/A = Not Applicable, Spain