Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation

Data collection methods

Primary data collection
Study drug and medical condition

Name of medicine, other

OraVerse
Population studied

Short description of the study population

Patients treated with OraVerse® after local anesthetic procedure (with a local anesthetic containing a vasoconstrictor) by dentists within the last 3 months before contract signing.

Age groups

Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

523
Study design details

Main study objective

The outcomes of interest will be the conditions of use of treatment. The primary outcomes will be the incidence of patients who “comply” / “not comply” with the recommendations in the SmPC regarding the following points:• Patient age class• Body weight class• Type of dental intervention• Local anesthetic used (product and dose)• Dose of OraVerse® used

Outcomes

The primary outcome was the proportion of patients that ‘comply’/’not comply’ with the conditions of use of OraVerse® according to the specifications in the Summary of Product Characteristics (SmPC). Dental interventions considered routine interventions were specified by the Company after discussion with the clinical expert.

Data analysis plan

Data collection: Dentists reported on conditions of use of OraVerse® from individual patients on ‘per-patient’ documentation forms.Safety data collection: retrospective detection of safety signals.Data management, review, validation: data collection was completely anonymous as requested by the authorities. Therefore, no backtracking was possible and no data quality control at site level was performed.Summary of statistical methods used: Data management and statistical analysis were performed using SAS, version 9.2. All study data were analyzed in an exploratory fashion by means of descriptive statistics.Compliance analysis: For the analysis of the primary outcome, the proportions of compliance and of non-compliance with the specifications in the SmPC were calculated for all compliance variables separately.