Administration, Topical, Administration, Topical Drug, Anesthetic Drugs
Conditions
Keywords
topical anesthetic, liposomal ropivacaine, dentistry
Brief summary
This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated ropivacaine formulations.
Detailed description
This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated 1 and 2% ropivacaine gel formulations.
Interventions
DRUGRopivacaine
100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Campinas, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 43 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy
Exclusion criteria
* Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After topical application of the local anesthetic formulations at the oral mucosa, their influence on pulpal response was assessed by an electrical pulp tester. | 10 minutes |
Secondary
| Measure | Time frame |
|---|---|
| The efficacy of the topical anesthetics was measured after a simulation of a local anesthesia in the application site (insertion of a 30 gauge needle until periosteum contact). | 10 seconds after removal of topical formulation |
Countries
Brazil
Outcome results
None listed