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Clinical evaluation of new local anesthetics for oral application

Efficacy and pharmacokinetics of new topical local anesthetic formulations for the oral mucosa

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7qnprq
Enrollment
Unknown
Registered
2020-01-30
Start date
2011-04-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wounds

Interventions

Topical application of local anesthetic: Group 1: 30 healthy volunteers received once in the bucal mucosa in one session EMLA® (2.5% of lidocaine and 2.5 % of prilocaine)- 60 mg
Group 2: 30 healthy volunteers received once in the bucal mucosa in one session EMLA® (2.5% of lidocaine and 2.5 % of prilocaine)- 10 mg
Group 3: 30 healthy volunteers received once in the bucal mucosa in one session Bioadhesive with 2.5% of lidocaine and 2.5 % of prilocaine- 10 mg Group 4: 30 healthy volunteers received once in the b
Drug
E01.370.600.550.324

Sponsors

Universidade São Francisco
Lead Sponsor
Universidade São Francisco
Collaborator

Eligibility

Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Age 20 to 45 years; Healthy; Students form graduation or post graduation from Universidade São Francisco or Universidade Estadual de Campinas; only the subjects having the upper right canine free of caries, large restorations, periodontal disease, past endodontic treatment, oral mucosal with no trauma or sensitivity were included.

Exclusion criteria

Exclusion criteria: Allergy to local anesthetic; cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and hematological diseases, psychiatric disorders; use of any medication, except oral contraceptives one week prior or during the experiment; smokers; addictive behavior with drugs or alcohol; pregnancy.

Design outcomes

Primary

MeasureTime frame
To obtain safer and more effective local anesthesia when compared to the commercial formulation (EMLA) determined by pulpal and oral mucosal sensibility test, and also by plasma levels of the local anesthetics. ;Bioadhesive formulation was able to promote soft tissue anesthesia equivalent to EMLA® when used at two different doses (10 and 60 mg). Theses formulations presented lower systemic absorption.

Countries

Brazil

Contacts

Public ContactGiovana Tofoli

Faculdade São Leopoldo Mandic

giovanatofoli@slmandic.edu.br55 19 3211-3600

Outcome results

None listed

Source: REBEC (via WHO ICTRP)