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The effect of botulinum toxin type A on reducing salivation and quality of life in patients with cerebral palsy

Evaluation of the effectiveness of botulinum toxin type A injection in reducing salivation and improving quality of life in patients with cerebral palsy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220516054868N1
Enrollment
30
Registered
2022-09-22
Start date
2022-06-26
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Cerebral palsy. Cerebral palsy

Interventions

Intervention group: For patients with cerebral palsy, first 500 units of botulinum toxin type A (Botox®, Masport, Iran) is diluted with 3 ml of normal saline. The child is placed in the supine positio

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 16 Years

Inclusion criteria

Inclusion criteria: Affliction cerebral palsy Drooling score more than 4

Exclusion criteria

Exclusion criteria: Contraindications for injection of Botulinum toxin A Botulinum toxin type A injection in three month ago Perform recent maxillofacial surgery that may interfere with saliva production and flow Receive systemic medication to treat sialorrhea in the last three months

Design outcomes

Primary

MeasureTime frame
The amount and intensity of saliva secretion based on drooling frequency and severity score. Timepoint: drooling frequency and severity Score before injection, 2 weeks after injection, one month, 2 months, 4 months and 6 months after injection. Method of measurement: drooling frequency and severity Score.

Secondary

MeasureTime frame
Quality of life score related to salivation based on a questionnaire. Timepoint: Before injection, 2 weeks after injection, one month, 2 months, 4 months and 6 months after injection. Method of measurement: Teacher drooling scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohadeseh Ghasemi

Esfahan University of Medical Sciences

ghasemi.mhd@gmai.com+98 31 3778 5759

Outcome results

None listed

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