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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01174329 |
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Date of registration:
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28/07/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Treatment of Salivary Gland Hypofunction With Neuro- Electrostimulation
SALELECTROSTIM |
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Scientific title:
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Difference in Salivary Flow in Patients With Salivary Gland Hypofunction of the Following Application of Neuro-electrostimulation |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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14 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01174329 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Mexico
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Contacts
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Name:
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María G Chapa Arizpe, Dr. |
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Address:
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Telephone:
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+52 81 83 46 62 62 |
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Email:
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maiech@hotmail.com |
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Affiliation:
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Name:
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Maria G Chapa Arizpe, Dr. |
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Address:
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Telephone:
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+52 81 8329 4230 |
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Email:
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maiech@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sjögren's Syndrome
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Xerostomia
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Polypharmacy
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Intervention(s)
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Device: Patient-regulated neuro-electrostimulation by "Saliwell Crown"
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Device: Automatic neuro-electrostimulation by "Saliwell Crown"
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Primary Outcome(s)
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self-reported xerostomia
[Time Frame: 4 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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