NCT00363207

Brief Summary

In children, behavior management is critical to the success of pediatric dental procedures. Most of the studies on local anesthesia performed in children deal with the question how to avoid or minimize pain during injection. Due to the sensation of numbness children scratch the soft tissues and bite lips and tongue. In many cases, this may be kept in children's memory as a "painful experience" and may affect their behavior in the following visit. The purpose of this study is to evaluate children's reactions to the administration of local anesthetic injection in the mandible (mandibular block) and in the maxilla (supraperiosteal infiltration), and to assess their behavior in the following visit related to each type of injection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2007

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 20, 2008

Status Verified

April 1, 2007

First QC Date

August 10, 2006

Last Update Submit

May 19, 2008

Conditions

Keywords

behaviorlocal anesthesiabehavior after dental local anesthesia

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children receiving routine dental treatment at the hadassah school of dental medicine

You may qualify if:

  • Age: 4-7
  • Behavior: Frankel 3-4
  • No sedation (premedication)
  • ASA 1
  • No dental treatment before
  • Need for similar treatment in the upper and lower jaw
  • No emergency treatment

You may not qualify if:

  • Need of premedication
  • Uneven treatment in each jaw

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hadassah School of Dental Medicine

Jerusalem, Jerusalem, 91120, Israel

Location

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • Diana Ram, Dr

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2006

First Posted

August 15, 2006

Study Start

May 1, 2007

Study Completion

May 1, 2008

Last Updated

May 20, 2008

Record last verified: 2007-04

Locations