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Comparing the effectiveness of electric stimulation therapy and pilocarpine mouthwash on salivary flow in patients with dry mouth: clinical trial

Comparing the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) and Pilocarpine mouthwash with standard care on salivary flow in patients with radiation-induced xerostomia: a randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065408
Enrollment
75
Registered
2024-04-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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: TENS therapy (2 session per week and 20 minutes per session for a period of 3 months): A device called transcutaneous electrical nerve stimulation (TENS) uses electric current that is m

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants who meet the eligibility requirements for the study are those who have completed radiation therapy with or without chemotherapy or surgery between three months and two years prior to study entry, and who report symptoms of oral dryness and decreased salivary flow (= 0.2 mL/min). All participants who are willing to give written informed consent.

Exclusion criteria

Exclusion criteria: Participants with a history of known salivary gland pathologies, such as rheumatoid arthritis and Sjogrens syndrome. Those who are taking drugs like pilocarpine, cevimeline, inhalatory glucocorticoids, opioids, benzodiazepines, diuretics, or who have undergone surgery involving the salivary glands. Participants with hearing aids, cochlear implants, pacemakers or defibrillators will be excluded from the study. Participants who have peptic ulcers or uncontrolled asthma will be excluded.

Design outcomes

Primary

MeasureTime frame
Changes in the salivary flowTimepoint: Baseline, 1month, 3 months and 6 months

Secondary

MeasureTime frame
OHI-S scores.Timepoint: Baseline, 1 month, 3 months and 6 months;Oral dryness.Timepoint: Baseline, 1 month, 3 months and 6 months;pH and viscosity of saliva.Timepoint: Baseline, 1 month, 3 months and 6 months;Quality of life.Timepoint: Baseline, 1 month, 3 months and 6 months

Countries

India

Contacts

Public ContactDr.Arpit Gupta

Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

arpitg.in@gmail.com8826674284

Outcome results

None listed

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