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Behavior of Children Related to Numbness After Dental Local Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00363207
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : May 20, 2008
Information provided by:
Hadassah Medical Organization

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.

Condition or disease
Anesthesia, Local Anesthesia, Dental

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Behavior of Children in the Following Appointment Related to Numbness Perception After Dental Local Anesthesia
Study Start Date : May 2007
Actual Study Completion Date : May 2008

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
children receiving routine dental treatment at the hadassah school of dental medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00363207

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Hadassah Medical Organization
Jerusalem, Israel, 91120
Hadassah School of Dental Medicine
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Diana Ram, Dr Hadassah Medical Organization
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Responsible Party: Diana Ram, Hadassah Medical Organization Identifier: NCT00363207    
Other Study ID Numbers: STDI-HMO-CTIL
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: April 2007
Keywords provided by Hadassah Medical Organization:
local anesthesia
behavior after dental local anesthesia
Additional relevant MeSH terms:
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Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases