Anesthesia, LocalNCT00363207
Behavior of Children Related to Numbness After Dental Local Anesthesia
An observational study of Anesthesia, Local and Anesthesia, Dental, run by Hadassah Medical Organization at 2 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local, Anesthesia, Dental
- How many people
- 100 participants
- Where
- 2 sitesIsrael
- Study dates
- May 2007to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children receiving routine dental treatment at the hadassah school of dental medicine
Who may be able to join
- 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
Who cannot join
- Need of premedication
- Uneven treatment in each jaw
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Hadassah School of Dental Medicine
Jerusalem, Jerusalem, 91120
Hadassah Medical Organization
Jerusalem, 91120
About this study
Official title: Behavior of Children in the Following Appointment Related to Numbness Perception After Dental Local Anesthesia
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.
Read the 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.
- Conditions
- Anesthesia, Local, Anesthesia, Dental
- Keywords
- behavior, local anesthesia, behavior after dental local anesthesia
- Medical subject headings
- Behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startMay 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Diana Ram, Dr, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363207
- Sponsor's protocol ID
- STDI-HMO-CTIL
- Status last verified
- Apr 2007
- First submitted
- 10 Aug 2006
- Last updated
- 20 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior of Children in the Following Appointment Related to Numbness Perception After Dental Local Anesthesia
- ClinicalTrials.gov ID
- NCT00363207
- Acronym / sponsor ID
- STDI-HMO-CTIL
- Conditions
- Anesthesia, Local, Anesthesia, Dental
- Keywords
- behavior, local anesthesia, behavior after dental local anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2007
- Study completion
- May 2008 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children receiving routine dental treatment at the hadassah school of dental medicine
Key inclusion criteria (7 listed)
- Age: 4-7
- Behavior: Frankel 3-4
- No sedation (premedication)
- ASA 1
- No dental treatment before
Key exclusion criteria (2 listed)
- Need of premedication
- Uneven treatment in each jaw
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Ram, Dr principal investigator
Hadassah Medical Organization
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Local and Anesthesia, Dental, run by Hadassah Medical Organization at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2008.