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Behavior of Children Related to Numbness After Dental Local Anesthesia

This study has been completed.
Information provided by Hadassah Medical Organization

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Descriptive Information Fields
Brief Title  Behavior of Children Related to Numbness After Dental Local Anesthesia
Official Title  Behavior of Children in the Following Appointment Related to Numbness Perception After Dental Local Anesthesia
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.

Detailed Description

Children between the ages of 4 to 7, undergoing dental treatment at the Department of Pediatric dentistry of the Hadassah School of Dental Medicine will participate in the study. All patients should be ASA Class I with no prior dental treatment who need at least two clinical sessions of similar operative procedures preceded by local anesthetic injection, one in each jaw, none of which due to emergency. Subjective and objective evaluation will be performed according to previously validated scales.

Study Phase
Study Type  Observational
Study Design  Case-Crossover, Prospective
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Anesthesia, Local
Anesthesia, Dental
Intervention 
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  100
Start Date  May 2007
Completion Date May 2008
Eligibility Criteria 

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Need of premedication
  • Uneven treatment in each jaw
Gender Both
Ages 4 Years to 8 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  Israel
Administrative Information Fields
NCT ID  NCT00363207
Organization ID STDI-HMO-CTIL
Secondary IDs ††
Study Sponsor  Hadassah Medical Organization
Collaborators ††
Investigators 
Principal Investigator:     Diana Ram, Dr     Hadassah Medical Organization    
Information Provided By Hadassah Medical Organization
Verification Date April 2007
First Received Date  August 10, 2006
Last Updated Date May 19, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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