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Topical Formulations of Liposomal Local Anesthetics

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01054547
First received: January 20, 2010
Last updated: January 21, 2010
Last verified: May 2006

January 20, 2010
January 21, 2010
September 2006
December 2006   (final data collection date for primary outcome measure)
After topical application of the local anesthetic formulations at the oral mucosa, their influence on pulpal response was assessed by an electrical pulp tester. [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01054547 on ClinicalTrials.gov Archive Site
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). [ Time Frame: 10 seconds after removal of topical formulation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Topical Formulations of Liposomal Local Anesthetics
Local Anesthetic Activity of Liposomal Formulations in Dentistry

This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated ropivacaine formulations.

This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated 1 and 2% ropivacaine gel formulations.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Health Services Research
  • Administration, Topical Drug
  • Administration, Topical
  • Anesthetic Drugs
  • Drug: Ropivacaine
    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.
    Other Name: Topical anesthesia in the palatal mucosa
  • Drug: Ropivacaine
    100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 20% benzocaine gel were applied once during 30 minutes.
    Other Name: Topical anesthesia in the buccal mucosa.
  • Placebo Comparator: Liposomal ropivacaine, topical
    The topical anesthetics were applied at the region of right and left maxillary lateral incisors at the buccal mucosa.
    Intervention: Drug: Ropivacaine
  • Placebo Comparator: Liposomal ropivacaine, palatal mucosa
    Topical formulations were applied at the palatal mucosa at the right canine region and efficacy of topical formulations was accessed through insertion of a 30 gauge needle and injection of anesthetic solution.
    Intervention: Drug: Ropivacaine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
April 2007
December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 43 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01054547
093/2006
Yes
Michelle Franz-Montan, Unicamp
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Not Provided
University of Campinas, Brazil
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP