A Stimulator of the Salivary Vibration of the Parotid Glands (saliva)

Universidad de Murcia

Status: Completed

Conditions: Saliva Stimulated

Treatments: Device: PHYSICAL VIBRATION OF THE PAROTID GLANDS

Study type: Interventional

Funder types: Other

Identifiers

NCT05129111

3338/2021

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Not signing informed consent
• Bad medical status

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

STIMULATOR OF THE SALIVARY EXCRETION BASED ON PHYSICAL VIBRATION

Active Comparator group

Description:

Measurement of salivary secretion at rest and stimulated conditions.

Treatment:

Device: PHYSICAL VIBRATION OF THE PAROTID GLANDS

STIMULATOR OF THE SALIVARY EXCRETION PLACEBO

Placebo Comparator group

Description:

Measurement of salivary secretion at rest and stimulated conditions.

Treatment:

Device: PHYSICAL VIBRATION OF THE PAROTID GLANDS