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Evaluation of the effect of lingual nerve stimulator on complete denture restoration

Evaluation of the efficacy of lingual nerve stimulator in improving the outcome of complete denture: a randomized, double-blind, parallel-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073870
Enrollment
Unknown
Registered
2023-07-24
Start date
2023-07-24
Completion date
Unknown
Last updated
2023-07-30

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

Conditions

Xerostomia Edentulism

Interventions

Lingual nerve stimulation treatment group:Electrical stimulation + mechanical stimulation
Placebo group:Mechanical stimulation

Sponsors

School of Stomatology, The Fourth Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1)Age 18 or above; 2) The unstimulated salivary flow rate was no more than 0.15mL/min, but the stimulated salivary flow rate was at least 2 times that of unstimulated salivary flow rate(If unstimulated saliva flow rate is 0, stimulated saliva more than 0 can be included); 3) The Kapur index of complete denture is less than 6; 4) Patients who have undergone complete denture restoration for more than 1 month; 5) Complete dentures are well made and fit with mucous membrane; 6)Patients who wear the complete denture have no pain, cheek biting, tongue biting, nausea and other discomfort symptoms; 7) Normal intelligence and mental condition, able to answer correctly, able to cooperate with the test; 8) Patients have been informed and has voluntarily signed written informed consent.

Exclusion criteria

Exclusion criteria: 1)HIV or active HBV or HCV infection; 2)Serious cardiopulmonary, liver, kidney, blood and other systemic diseases; 3)Patients receiving chemoradiotherapy for head and neck tumors with a history of transplantation; 4)Participants using anticoagulants; 5)Allergic to lingual nerve stimulation devices; 6)Having an intellectual or psychological disorder; 7)Wear a pacemaker, a defibrillator, a hearing aid; 8)Epilepsy and involuntary muscle movement disorders (such as Parkinson's or Hoddington's disease); 9)Pregnancy 10)Patients with chronic or recurrent erosive or ulcerative or precancerous or malignant oral lesions;

Design outcomes

Primary

MeasureTime frame
Improvement of retaining force of complete denture;Improvement of retaining force of complete denture;

Secondary

MeasureTime frame
Unstimulated and stimulated salivary flow;Distribution and change of bite force;Changes in the severity of dry mouth;Improvements in quality of life;Patients' satisfaction with the complete denture after treatment;

Countries

China

Contacts

Public ContactLina Niu

School of Stomatology, The Fourth Military Medical University

1252250061@qq.com+86 176 3022 5015

Outcome results

None listed

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