Skip to content

Wearable Wireless device to improve volume of saliva in elderly persons

Salivary Stimulatory Effect of Novel Low level Transcutaneous Electro Neurostimulator in Geriatric patients with Xerostomia

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/048686
Enrollment
150
Registered
2023-01-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K117- Disturbances of salivary secretion

Interventions

Intervention1: Transcutaneous Electrical Nerve Stimulation using a custom designed device: Participants were asked to use the device continuously twice daily (morning and evening), for 10 minutes with

Sponsors

Rajkumar Krishnan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Elderly patients of the age of 60 and above were screened for signs of "dry mouth" based on the "Challacombe Scale of clinical oral dryness". 2. Patients presenting with a subjective complaint of oral dryness and hyposalivation and salivary flow rate 0.2 ml/min or less.

Exclusion criteria

Exclusion criteria: Participants with known history of salivary gland pathologies Participants with known history of sjogrens sydrome or rhematoid arthiritis pacemakers Participants with known history of pcardiac pacemakers or defibrillators Participants with known history of using hearing aids or cochlear implants Participants with known history or undergone any surgical or radiotherapy procedure or involving the salivary glands Participants with known history medication induced xerostomia

Design outcomes

Primary

MeasureTime frame
1. Salivary Flow Timepoint: 1. Salivary Flow 0th 3rd 6th 9th 12th 15th month

Secondary

MeasureTime frame
2. Salivary pH 3. Salivary cortisol 4. Salivary anti-oxidant Capacity 5. Salivary total protein 6. Viscosity of saliva 7. Salivary microbial carriage 8. Quality of lifeTimepoint: 2. Salivary pH 0th 3rd 6th 9th 12th 15th month 3. Salivary cortisol 0th 3rd 6th 9th 12th 15th month 4. Salivary anti-oxidant Capacity 0th 3rd 6th 9th 12th 15th month 5. Salivary total protein 0th 3rd 6th 9th 12th 15th month 6. Viscosity of saliva 0th 3rd 6th 9th 12th 15th month 7. Salivary microbial carriage 0th 3rd 6th 9th 12th 15th month 8. Quality of life Pre and post trial.

Countries

India

Contacts

Public ContactNagarathinam A

SRM Dental College, Ramapuram Chennai

vp.dental.rmp@srmist.edu.in9500058376

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026