Behavior of Children Related to Numbness After Dental Local Anesthesia

Completed

• Conditions: Anesthesia, Local; Anesthesia, Dental

• Registration Number: NCT00363207
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2006-08-10
• Study First Submitted QC: 2006-08-10
• Study First Posted: 2006-08-15
• Status Verified: 2007-04
• Study Start: 2007-05
• Study Completion: 2008-05
• Last Update Submitted: 2008-05-19
• Last Update Posted: 2008-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel

Hadassah School of Dental Medicine; 🇮🇱 Jerusalem, Israel