Masticatory muscle hyperactivity/bruxism in patients with Cerebral Palsy. MedDRA version: 14.1 Level: HLGT Classification code 10028037 Term: Movement disorders (incl parkinsonism) System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Botox Allergan
Product Name: Botox
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: Botulinum Toxin type A
CAS Number: 93384-43-1
Other descript
Sponsors
Folktandvården Västra Götaland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willingness to participate 2. Female and male aged 18 years or older 3. CP with masticatory muscle hyperactivity/bruxism 4. Obvious tooth wear 5. Capabillity to decide 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 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Inability to understand the study and complete the questionnaire 2. Patients with known hypersensitivity to Botox 3. Patients with any infection in the injection site 4. Treatment with BTX-A injection last month 5. Medication with aminoglycoside antibiotics, spectinomycin and neuromuskular blockers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to evaluate if injections with botulinum toxin in persons with cerebral palsy and severe bruxism/parafunction in masticatory muscles reduce the bite force without any adverse effects. ;Secondary Objective: Secondary objectives are: - To evaluate if it is possible to identify responders after one injection - Patient-reported outcomes including bruxism, pain, chewing- and speech ability and oral health-quality of life - To evaluate mandibular movements in function, before and after injcection;Primary end point(s): - Bite force, measured with a bite fork, peak at maximal clenching during 3 sec, mean of 3 tests. - Bite force as "chewing", measured with a bite fork, mean of 5 tests.;Timepoint(s) of evaluation of this end point: 4, 12 and 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Patient Reported Outcomes assessed by VAS and a swedish version of General Oral Health Assessment Index, GOHAI. - Mandibular jaw mowement, measured with SmartEye Pro - MME;Timepoint(s) of evaluation of this end point: 4, 12 and 16 weeks. | — |
Countries
Sweden
Contacts
Public ContactBirgitta Johansson Cahlin
Folktandvården Västra Götaland
Outcome results
None listed