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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

Diana Ram, Dr      +972 544747580    dianar@md.huji.ac.il
Hadas Lemberg, PhD      +972 2 6777572    lhadas@hadassah.org.il

Israel
Hadassah 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:  NCT00363207
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2006-09-29





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