Saliva StimulatedsalivaNCT05129111
A Stimulator of the Salivary Vibration of the Parotid Glands
A study testing PHYSICAL VIBRATION OF THE PAROTID GLANDS in people with Saliva Stimulated, run by Universidad de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Saliva Stimulated
- What is being tested?
- PHYSICAL VIBRATION OF THE PAROTID GLANDS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 12 May 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sialometria <01,mL /5 min
- Test Thomson
Who cannot join
- Not signing informed consent
- Bad medical status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Stimulator of the Salivary Excretion Based on Physical Vibration of the Parotid Glands.
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
- Conditions
- Saliva Stimulated
- Being tested
- PHYSICAL VIBRATION OF THE PAROTID GLANDS
- Keywords
- saliva
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHYSICAL VIBRATION OF THE PAROTID GLANDSDevice
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
| Study group | Role | What they receive |
|---|---|---|
| STIMULATOR OF THE SALIVARY EXCRETION BASED ON PHYSICAL VIBRATION | Active comparator | Measurement of salivary secretion at rest and stimulated conditions. Receives: Device: PHYSICAL VIBRATION OF THE PAROTID GLANDS |
| STIMULATOR OF THE SALIVARY EXCRETION PLACEBO | Placebo comparator | Measurement of salivary secretion at rest and stimulated conditions. Receives: Device: PHYSICAL VIBRATION OF THE PAROTID GLANDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start12 May 2021
- Primary completion3 Jul 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Saliva StimulatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pia Lopez Jornet, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129111
- Sponsor's protocol ID
- 3338/2021
- Acronym
- saliva
- Status last verified
- Nov 2021
- First submitted
- 1 Nov 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33191538Salimi 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.
PubMed 33664943
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stimulator of the Salivary Excretion Based on Physical Vibration of the Parotid Glands.
- ClinicalTrials.gov ID
- NCT05129111
- Acronym / sponsor ID
- saliva / 3338/2021
- Conditions
- Saliva Stimulated
- Keywords
- saliva
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 3 Jul 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| STIMULATOR OF THE SALIVARY EXCRETION BASED ON PHYSICAL VIBRATION | Active comparator | Device: PHYSICAL VIBRATION OF THE PAROTID GLANDSMeasurement of salivary secretion at rest and stimulated conditions. |
| STIMULATOR OF THE SALIVARY EXCRETION PLACEBO | Placebo comparator | Device: PHYSICAL VIBRATION OF THE PAROTID GLANDSMeasurement of salivary secretion at rest and stimulated conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sialometria <01,mL /5 min
- Test Thomson
Key exclusion criteria (2 listed)
- Not signing informed consent
- Bad medical status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHYSICAL VIBRATION OF THE PAROTID GLANDSThe system will be placed bilaterally in the parotid glands and assessed the efficacy of the salivary secretion by sialometry before and after the stimulation | Device | STIMULATOR OF THE SALIVARY EXCRETION BASED ON PHYSICAL VIBRATION, STIMULATOR OF THE SALIVARY EXCRETION PLACEBO |
Primary outcome
sialometry
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Background: PubMed 33191538Fernandes 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.
- Background: PubMed 33664943Salimi 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHYSICAL VIBRATION OF THE PAROTID GLANDS in people with Saliva Stimulated, run by Universidad de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sialometry (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05129111, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.