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A Stimulator of the Salivary Vibration of the Parotid Glands

NCT ID: NCT05129111

Last Updated: 2021-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-12

Study Completion Date

2021-09-01

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

Detailed Description

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Conditions

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Saliva Stimulated

Keywords

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saliva

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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STIMULATOR OF THE SALIVARY EXCRETION BASED ON PHYSICAL VIBRATION

Measurement of salivary secretion at rest and stimulated conditions.

Group Type ACTIVE_COMPARATOR

PHYSICAL VIBRATION OF THE PAROTID GLANDS

Intervention Type DEVICE

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

STIMULATOR OF THE SALIVARY EXCRETION PLACEBO

Measurement of salivary secretion at rest and stimulated conditions.

Group Type PLACEBO_COMPARATOR

PHYSICAL VIBRATION OF THE PAROTID GLANDS

Intervention Type DEVICE

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

Interventions

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PHYSICAL VIBRATION OF THE PAROTID GLANDS

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Sialometria \<01,mL /5 min
* Test Thomson

Exclusion Criteria

* Not signing informed consent
* Bad medical status
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Pia Lopez Jornet

Investigador principal

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lopez-Jornet Pia

Murcia, N/A = Not Applicable, Spain

Site Status

Countries

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Spain

References

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Fernandes MS, Castelo PM, Chaves GN, Fernandes JPS, Fonseca FLA, Zanato LE, Gaviao MBD. Relationship between polypharmacy, xerostomia, gustatory sensitivity, and swallowing complaints in the elderly: A multidisciplinary approach. J Texture Stud. 2021 Apr;52(2):187-196. doi: 10.1111/jtxs.12573. Epub 2020 Nov 25.

Reference Type BACKGROUND
PMID: 33191538 (View on PubMed)

Salimi F, Saavedra F, Andrews B, FitzGerald J, Winter SC. Trans-cutaneous electrical nerve stimulation to treat dry mouth (xerostomia) following radiotherapy for head and neck cancer. A systematic review. Ann Med Surg (Lond). 2021 Feb 3;63:102146. doi: 10.1016/j.amsu.2021.01.094. eCollection 2021 Mar.

Reference Type BACKGROUND
PMID: 33664943 (View on PubMed)

Other Identifiers

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3338/2021

Identifier Type: -

Identifier Source: org_study_id