How affect the salivary gland treatment with Botulinum neurotoxin type A oral health in patients suffer for drooling?

Phase 1

• Conditions: Hypersalivation; MedDRA version: 18.0Level: LLTClassification code 10020746Term: HypersalivationSystem Organ Class: 100000004856; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2015-000682-30-EE
• Lead Sponsor: Tartu University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-16
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

BNT-A injections into salivary glands is used to treat patients suffering average and hard hypersalivation.
•The aetiology of sialorrhea is caused by chronic neurodegenerative diseases.
•The severity of sialorrhea is calculated using Item 2.2 from Part I (Non-Motor Aspects of Experiences of Daily Living) of the Unified Parkinson’s Disease Rating Scale (Goetz et al., 2008)
•The cases when logopedical treatment with chewing muscle and m. orbicularis oris myogymnastics do not decrease the saliva flow.

The first control group participants are selected during routine dentist visits at Tartu University Hospital
•Requirement is that they have to be healthy human volunteers with the same age group.

The second control group are selected during routine neurologist visits.
•Parkinson´s disease patients without sialorrhea. The severity of sialorrhea is calculated using Item 2.2 from Part I (Non-Motor Aspects of Experiences of Daily Living) of the Unified Parkinson’s Disease Rating Scale (Goetz et al., 2008)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

•During the study, no medication that could influence the severity of drooling is allowed.
•Patients with other sialorrhea treatment will be excluded from the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified