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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00363207
Other study ID # STDI-HMO-CTIL
Secondary ID
Status Completed
Phase N/A
First received August 10, 2006
Last updated May 19, 2008
Start date May 2007
Est. completion date May 2008

Study information

Verified date April 2007
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 4 Years to 8 Years
Eligibility 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

Observational Model: Case-Crossover, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem
Israel Hadassah School of Dental Medicine Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

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