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

Phase 2

Recruiting

• Conditions: cerebral palsy; sialorrhea.; Cerebral palsy

• Registration Number: IRCT20220211053995N1
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 8 March 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.