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The effect of Botulinum type A on sialorrhea in patients with cerebral palsy

The effect of Botulinum toxin type A on reducing sialorrhea in patients with cerebral palsy in Akbar Children's Hospital

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220211053995N1
Enrollment
20
Registered
2022-02-20
Start date
2022-02-20
Completion date
Unknown
Last updated
2022-03-08

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

Conditions

cerebral palsy

Interventions

Intervention group: Vial toxin botulinum type A (massport) diluted with 3.2 cc of normal saline and depending on the patient's weight in each salivary gland 30 to 50 units (less than 15 kg 30 units, b

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 16 Years

Inclusion criteria

Inclusion criteria: patients with cerebral palsy Drooling frequency scale 4 and severity and Teacher scale more than 4 Age between 4 and 16 years Consent of parents or legal guardians to enter the study

Exclusion criteria

Exclusion criteria: Contraindications of botulinum toxin A injection such as myasthenia gravis and Eaton-Lambert syndrome Botulinum toxin A injection for at least the last four months Receiving systemic medication to treat sialorrhea in the last three months Recent maxillofacial surgery that may interfere with saliva production and flow.

Design outcomes

Primary

MeasureTime frame
Drooling frequency score based on Drooling frequency scale and Teacher drooling scale. Timepoint: Before intervention, 2 weeks, 1 month, 2 months, 4 months, 6 months and 9 months after botulinum toxin injection. Method of measurement: Drooling Frequency and Teacher drooling scale.;Drooling severity score based on Drooling severity scale and Teacher drooling scale. Timepoint: Before intervention, 2 weeks, 1 month, 2 months, 4 months, 6 months and 9 months after botulinum toxin injection. Method of measurement: Drooling Severity and Teacher drooling scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Javad Sayedi

Mashhad University of Medical Sciences

nazariradm991@mums.ac.ir+98 51 3870 9201

Outcome results

None listed

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