XerostomiaPhase 2/3SALELECTROSTIMNCT01174329
Treatment of Salivary Gland Hypofunction With Neuro- Electrostimulation
A Phase 2/3 study testing Automatic neuro-electrostimulation by "Saliwell Crown" and Patient-regulated neuro-electrostimulation by "Saliwell Crown" in people with Xerostomia and Polypharmacy, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial summary
The objective of the study is to evaluate with clinical parameters the performance of Saliwell Crown as a neuro-electrostimulator of the submandibular and sublingual salivary glands in hypofunction status due to polypharmacy or Sjögren's Syndrome in patients with symptoms of xerostomia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Xerostomia, Polypharmacy, Sjögren's Syndrome
- What is being tested?
- Automatic neuro-electrostimulation by "Saliwell Crown" and Patient-regulated neuro-electrostimulation by "Saliwell Crown"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2010to Dec 2010
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range between 18 and 75 years of age
- Clinical symptoms of xerostomia
- Difference in whole salivary flow between resting and stimulating conditions
- Patient ASA type I to III
- Absence of at least one mandibular third molar inferior, but at least partially dentated in the mandible
Who cannot join
- Patients with antimicrobial treatments in the three previous months
- Smokers
- Intake of bisphosphonates
- Limitation of mandibular opening
- Interoclusal distance smaller than 10 millimetres
- Lack of adequate bone availability for implant placement
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
C.D. Especialidad de Periodoncia
Monterrey, Nuevo León
María G Chapa Arizpe, Dr., +52 81 83 46 62 62, maiech@hotmail.com
+52 81 83 29 42 50
About this study
Official title: Difference in Salivary Flow in Patients With Salivary Gland Hypofunction of the Following Application of Neuro-electrostimulation
The objective of the study is to evaluate with clinical parameters the performance of Saliwell Crown as a neuro-electrostimulator of the submandibular and sublingual salivary glands in hypofunction status due to polypharmacy or Sjögren's Syndrome in patients with symptoms of xerostomia.
- Conditions
- Xerostomia, Polypharmacy, Sjögren's Syndrome
- Being tested
- Automatic neuro-electrostimulation by "Saliwell Crown", Patient-regulated neuro-electrostimulation by "Saliwell Crown"
- Medical subject headings
- Xerostomia, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic neuro-electrostimulation by "Saliwell Crown"Device
Continuous stimulation of the lingual nerve by "Saliwell Crown"
Patient-regulated neuro-electrostimulation by "Saliwell Crown"Device
On-demand stimulation of the lingual nerveby "Saliwell Crown"
| Study group | Role | What they receive |
|---|---|---|
| Patient-regulated neuro-electrostimulation by "Saliwell Crown" | Experimental | Patient regulated (by a remote control) neuro-electrostimulation by "Saliwell Crown" Receives: Device: Patient-regulated neuro-electrostimulation by "Saliwell Crown" |
| Automatic neuro-electrostimulation by "Saliwell Crown" | Active comparator | No remote control used Receives: Device: Automatic neuro-electrostimulation by "Saliwell Crown" |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported xerostomia
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174329
- Sponsor's protocol ID
- 1234
- Acronym
- SALELECTROSTIM
- Status last verified
- Jul 2010
- First submitted
- 28 Jul 2010
- Last updated
- 18 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference in Salivary Flow in Patients With Salivary Gland Hypofunction of the Following Application of Neuro-electrostimulation
- ClinicalTrials.gov ID
- NCT01174329
- Acronym / sponsor ID
- SALELECTROSTIM / 1234
- Conditions
- Xerostomia, Polypharmacy, Sjögren's Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (estimated)
- First posted
- 3 Aug 2010 (estimated)
- 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.
The objective of the study is to evaluate with clinical parameters the performance of Saliwell Crown as a neuro-electrostimulator of the submandibular and sublingual salivary glands in hypofunction status due to polypharmacy or Sjögren's Syndrome in patients with symptoms of xerostomia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-regulated neuro-electrostimulation by "Saliwell Crown" | Experimental | Device: Patient-regulated neuro-electrostimulation by "Saliwell Crown"Patient regulated (by a remote control) neuro-electrostimulation by "Saliwell Crown" |
| Automatic neuro-electrostimulation by "Saliwell Crown" | Active comparator | Device: Automatic neuro-electrostimulation by "Saliwell Crown"No remote control used |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age range between 18 and 75 years of age
- Clinical symptoms of xerostomia
- Difference in whole salivary flow between resting and stimulating conditions
- Patient ASA type I to III
- Absence of at least one mandibular third molar inferior, but at least partially dentated in the mandible
Key exclusion criteria (6 listed)
- Patients with antimicrobial treatments in the three previous months
- Smokers
- Intake of bisphosphonates
- Limitation of mandibular opening
- Interoclusal distance smaller than 10 millimetres
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 |
|---|---|---|
| Automatic neuro-electrostimulation by "Saliwell Crown"Continuous stimulation of the lingual nerve by "Saliwell Crown" | Device | Automatic neuro-electrostimulation by "Saliwell Crown" |
| Patient-regulated neuro-electrostimulation by "Saliwell Crown"On-demand stimulation of the lingual nerveby "Saliwell Crown" | Device | Patient-regulated neuro-electrostimulation by "Saliwell Crown" |
Primary outcome
self-reported xerostomia
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Automatic neuro-electrostimulation by "Saliwell Crown" and Patient-regulated neuro-electrostimulation by "Saliwell Crown" in people with Xerostomia and Polypharmacy, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Aug 2010. 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 Mexico. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria G Chapa Arizpe, Dr. (+52 81 8329 4230, maiech@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-reported xerostomia (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2010.