Behavior of Children Related to Numbness After Dental Local Anesthesia
This study is not yet open for patient recruitment
Verified by Hadassah Medical Organization August 2006
| Sponsored by: |
Hadassah Medical Organization |
| Information provided by: |
Hadassah Medical Organization |
| ClinicalTrials.gov Identifier: |
NCT00363207 |
Purpose
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 |
| Behavior After Dental Local Anesthesia |
Study Type: Observational
Study Design: Psychosocial, Cross-Sectional, Case Control, Prospective Study
Official Title: Behavior of Children in the Following Appointment Related to Numbness Perception After Dental Local Anesthesia
Further study details as provided by Hadassah Medical Organization:
Expected Total Enrollment:
100
Study start: October 2006;
Expected completion: December 2007
Last follow-up: October 2007;
Data entry closure: October 2007
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.
Eligibility
Ages Eligible for Study:
4 Years
-
8 Years,
Genders Eligible for Study:
Both
Accepts Healthy Volunteers
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
-
Location
and Contact
Information
Please refer to this study by ClinicalTrials.gov identifier
NCT00363207
IsraelHadassah Medical Organization, Jerusalem,
91120,
Israel
Diana Ram, Dr
+972 544747580
dianar@md.huji.ac.il
Esti Davidovich, Dr, Principal Investigator Erica Amir, Dr, Sub-Investigator
Study chairs or principal investigators
Diana Ram, Dr, Principal Investigator, Hadassah Medical Organization
More Information
Study ID Numbers:
STDI-HMO-CTIL
Last Updated:
September 4, 2006
Record first received:
August 10, 2006
ClinicalTrials.gov Identifier:
NCT00363207Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration ClinicalTrials.gov processed this record on 2006-09-29 |
