Completed

NCT Number: NCT01307969

Formulations of Liposomal Local Anesthetics

This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated ropivacaine formulation for dental anesthesia.

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Key information

Conditions

Underdosing of Local Anesthetics, Initial Encounter

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Piracicaba Dental School

Piracicaba, São Paulo, Brazil

About this study

This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated 0, 5% ropivacaine for dental anesthesia after maxillary infiltration.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

1,8 mL of the local anesthetic formulations were injected at the apex of the maxillary right canine.

Other names: 0,5% ropivacaine encapsulated in liposomes, 0,5% ropivacaine with epinephrine 1:200.000, 2% lidocaine with epinephrine 1:100.000

Primary outcomes

After anesthetic injection the pulpal response was assessed by an electrical pulp tester.

Time frame: 100 minutes

Secondary outcomes

Duration of soft tissue anesthesia was measured as the time from beginning to end of lip and gingival numbness.

Time frame: 240 minutes

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Formulations of Liposomal Local Anesthetics for Dental Anesthesia

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Mar 3, 2011
Registry last updated: Mar 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.