Patients with dental decay, root canal treatment or tooth to be extracted will be studied
Conditions
Interventions
Trade Name: ORAVERSE (Phentolamine Mesylate)
Product Name: ORAVERSE ( Mesylate Phentolamine)
Product Code: 6 884 450 4
Pharmaceutical Form: Solution for injection in cartridge
INN or Proposed INN: PHE
Sponsors
ULB ERASME
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Critères d’inclusions : - Patients from 10 to 65 years. Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Critères d’exclusions : - Patients less than 10 years. - Patients presenting former contraindication with receiving adrenaline injection ( common local anesthesia) (Asmathique cortico-dépendant, cancer of former cancer of adrenal gland, pregnant woman, Patient with diabete uncontrolled).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Showing that the utilisation of Phentolamines mesylates, statistically reduced the residual anaesthesia after a dental routine care rather than no utilisation.;Secondary Objective: Comparison of satisfaction induced for the patients by answering a questionnaire.;Primary end point(s): Reaching the number of patients required (40) ;Timepoint(s) of evaluation of this end point: MAY 2020 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Reaching timepoint N*1;Timepoint(s) of evaluation of this end point: May 2020 | — |
Countries
Belgium
Contacts
Public ContactINVESTIGATOR
ERASME ULB
Outcome results
None listed