Lingual nerve stimulator in patients wearing orthodontic devices: a randomized, double-blind, parallel-controlled clinical trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300075809

Enrollment

Unknown

Registered

2023-09-15

Start date

2023-09-25

Completion date

Unknown

Last updated

2023-09-18

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

Conditions

Oral disease

Interventions

Lingual nerve stimulator experimental group:The subjects received electrical stimulation of the lingual nerve

Lingual nerve stimulator control group:The subjects were given false electrical stimulation of the lingual nerve

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1) Age 18-40 years old (including 18 and 40 years old), regardless of gender; 2) No systematic periodontal therapy has been performed within 1 year; 3) No antibiotics have been taken in the past two months; 4) No severe periodontitis, good compliance; 5) in the stage of orthodontic treatment; 6) Poor oral hygiene, poor self-cleaning effect, or once prone to caries or gingival red bleeding; 7) Normal intelligence and mental condition, able to answer correctly, able to cooperate with the test 8) The subject is aware of the situation and voluntarily signs a written informed consent form.

Exclusion criteria

Exclusion criteria: 1) HIV or active HBV or HCV infected persons; 2) serious systemic diseases such as heart, lung, liver, kidney and blood; 3) Patients receiving radiotherapy and chemotherapy for head and neck tumors, and patients with transplant history; 4) Use anticoagulants; 5) Allergic to lingual nerve stimulation materials; 6) Have intellectual, mental or psychological disabilities; 7) Wear pacemakers, defibrillators and hearing AIDS; 8) Epilepsy and involuntary muscle movement disorders (such as Parkinson's disease or Hoddington's disease); 9) pregnancy; 10) Patients with chronic or recurrent, erosive or ulcerative, or precancerous or malignant oral lesions; 11) Patients with severe gingivitis, periodontitis, and poor oral hygiene.

Design outcomes

Primary

Measure	Time frame
PLI;GI;	—

Secondary

Measure	Time frame
Static saliva flow;Caries susceptibility test;Oral Odor Visual Analog Scale Score;Analysis of oral microbiota;	—

Countries

China

Contacts

Public ContactLina Niu

Third Air Force Medical University Hospital

2744404972@qq.com+86 159 5566 4721

Outcome results

None listed

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