Premedication in dentistry MedDRA version: 21.0 Level: PT Classification code 10036500 Term: Premedication System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: OXYTOCIN AVMC 5IU/ml
Product Name: Oxytocin
Pharmaceutical Form: Injection/infusion
INN or Proposed INN: Oxytocin
CAS Number: 50-56-6
Other descriptive name: OXYTOCIN
Concentration unit: I
Sponsors
Dentlabe s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent signed 2. Volunteers - male and female subjects 3. 18 - 65 years of age 4. Diagnosis odontophobia Dg F40.2, or common fear of dentist at healthy patient 5. Endodontic treatment with rubber dam 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 44 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients where treatment of oxytocin id contraindicated 2. Patients with history of allergy to oxytocin 3. Pregnancy, breastfeeding 4. Pathology of uterus in patient´s history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if oxytocin can be used as premedication in dentistry;Secondary Objective: Not applicable;Primary end point(s): Discontinuation from treatment for case of adverese events.;Timepoint(s) of evaluation of this end point: Discontinuation from treatment for case of adverese events | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Side effects appear.;Timepoint(s) of evaluation of this end point: 2 hours | — |
Countries
Czech Republic
Contacts
Public ContactOndrej Kohout
Dentlabe s.r.o.
Outcome results
None listed