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A multicenter, randomized, double blind, parallel controlled clinical trial of lingual nerve stimulator in the treatment of xerostomia

A multicenter, randomized, double blind, parallel controlled clinical trial of lingual nerve stimulator in the treatment of xerostomia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049115
Enrollment
Unknown
Registered
2021-07-21
Start date
2021-08-04
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Xerostomia

Interventions

Lingual nerve stimulation group:Electrical stimulation+mechanical stimulation
Control group:Mechanical stimulation

Sponsors

The Third Affiliated Hospital of Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 70 years (including 18 and 70 years old); 2.With symptoms of dry mouth; 3.The static saliva flow rate is less than or equal to 0.1mL/min, but the irritating saliva flow rate is at least twice the static saliva flow rate; 4.Normal intelligence and mental status, able to answer correctly, and able to cooperate with the experiment; 5.The subject knows the situation and voluntarily signs a written informed consent.

Exclusion criteria

Exclusion criteria: 1.HIV or active HBV or HCV infection; 2.Severe heart, lung, liver, kidney, blood and other systemic diseases; 3.Patients who have received radiotherapy and chemotherapy due to head and neck tumors, and those who have a history of transplantation; 4.Use anticoagulant; 5.Allergic to tongue nerve stimulator materials; 6.Have intellectual, mental or psychological disorders; 7.Wear pacemakers, defibrillators, and hearing aids; 8.Epilepsy and involuntary muscle movement disorders (such as Parkinson's syndrome or Hoddington's disease); 9.Pregnancy; 10.Edentulous jaw; 11.Patients with chronic or recurrent, erosive or ulcerative or precancerous or malignant oral lesions; 12.Other patients deemed unsuitable for enrollment by the investigator.

Design outcomes

Primary

MeasureTime frame
Severity of dry mouth;

Secondary

MeasureTime frame
Static and irritant total saliva flow measurements;Oral health-related quality of life evaluation;Salivary power of hydrogen;

Countries

China

Contacts

Public ContactJiao Kai

Stomatological Hospital of Air Force Medical University

kjiao1@163.com+86 13571941770

Outcome results

None listed

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