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Clinical study of botulinum toxin A in the treatment of salivary gland benign hypertrophy

Botulinum toxin Type A injection for salivary gland benign hypertrophy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037934
Enrollment
Unknown
Registered
2020-09-04
Start date
2020-09-01
Completion date
Unknown
Last updated
2021-01-11

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

Conditions

Salivary gland benign hypertrophy

Interventions

The treatment group:Botulinum toxin A injection

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years old; 2. Patients without basic diseases; 3. Patients with benign enlargement of salivary glands without obvious symptoms and without sialopathy.

Exclusion criteria

Exclusion criteria: 1. Patients with benign or malignant parotid / submandibular gland tumors; 2. Patients with parotid / submandibular gland skin infection or ulceration; Patients with allergy to botulinum toxin type A; 4. Patients with neuromuscular diseases, such as myasthenia gravis, Lambert Eaton syndrome, motor neuropathy or amyotrophic lateral sclerosis; 5. Patients receiving aminoglycoside antibiotics, penicillin, quinine or calcium channel blockers (can be used after withdrawal). 5. Patients with abnormal local anatomy; 6. Pregnant and lactating women; 7. Patients with severe heart, lung, liver and kidney diseases.

Design outcomes

Primary

MeasureTime frame
Parotid/submandibular volume;Facial standard photograph;Visual Analogue Scale;

Secondary

MeasureTime frame
The distance from screen front midpoint to mandibular Angle;The distance from the lower margin of mastoid process to the highest point of masseter muscle;

Countries

China

Contacts

Public ContactLi Guangshuai

The First Affiliated Hospital of Zhengzhou University

liguangshuai@zzu.edu.cn+86 13838062386

Outcome results

None listed

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