Wearable Wireless device to improve volume of saliva in elderly persons

Phase 2

• Conditions: Health Condition 1: K117- Disturbances of salivary secretion

• Registration Number: CTRI/2023/01/048686
• Lead Sponsor: Rajkumar Krishnan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Salivary Flow <br/ ><br>Timepoint: 1. Salivary Flow 0th 3rd 6th 9th 12th 15th month

Secondary Outcome Measures

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