Anesthetic Efficacy of Liposomal Prilocaine in Maxillary... | NCT01073371

Studies
Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia

NCT01073371

Sponsor

University of Campinas, Brazil

Status

Completed

Last Update Posted

Feb 23, 2010Estimated

Enrollment

32Actual

Phase

Phase 1

Conditions

Dental Anesthesia Efficacy

Interventions

Prilocaine

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Feb 19, 2010

First Submission Date that Met QC Criteria

Feb 22, 2010

First Posted Date

Feb 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2010

Last Update Posted Date

Feb 23, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of Campinas, BrazilOTHER

Collaborators

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
liposome-encapsulated 3% prilocaine	Active Comparator	Drug: Prilocaine
3% plain prilocaine	Active Comparator	Drug: Prilocaine
3% prilocaine with 0,03IU/mL felypressin	Active Comparator	Drug: Prilocaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prilocaine	Drug	1.8mL infiltration of liposome-encapsulated 3% prilocaine, 3% plain prilocaine or 3% prilocaine with 0,03IU/mL felypressin in the buccal sulcus of the maxillary right canine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anesthesia success, onset and duration of pulpal and gingival anesthesia.		10 minutes

Secondary Outcomes

Measure	Description	Time Frame
Injection pain - Visual Analogue Scale		1 minute after the injections

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

good health
no history of allergy to the components of the local anesthetic formulations tested
maxillary canine, lateral incisor, and first premolar responsible to electric stimulation

Exclusion Criteria:

intake of any medication that would alter pain perception
history of trauma or sensitivity, caries, restorations, periodontal disease and endodontic treatment in the maxillary canine, lateral incisor, and first premolar
systemic disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eneida de Paula, PhD	University of Campinas, Brazil	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Piracicaba Dental School		Piracicaba	São Paulo	13414903	Brazil

Intervention Browse Module

MeSH Terms

ID	Term
D011318	Prilocaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided