The aim of this study is to compare the pain and distress response of children during the application of local anaesthesia injection using a computerized device (the Wand ® or the Sleeper One®) and during the following dental treatment.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
caries
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
wand, sleeper one
Secondary outcome
age, first or second treatment
Background summary
Of Dutch children aged 4 to 11 years, 14% is afraid of dental treatment. An
important factor which makes dental treatment as unpleasant is the pain a
treatment can bring. With the improvement in detistry is the pain during the
dental treatment decreased. However, the local anesthesia is for both children
and adults the most anxiety-producing procedure at the dentist.
The presence of anxiety in children can result in behavioral management
problems that makes treatment difficult. One possibility to reduce this
behaviorproblems is to try to reduce the pain and discomfort during treatment
to a minimum. Increasing the injection time has helped in reducing pain during
local anesthesia. The pain during the anesthetic injection is partially caused
by the high pressure on the nerve during the injection. Increasing the
injection time , the pressure on the nerve cells is limited.
When WAND ® and Sleeper One ® are used, both local anesthetic delivery systems
for medical and dental use, the amount of anesthetic liquid that is injected
controlled by a computer, the pressure is lower than the gums can endure. The
gums can therefore absorb the liquid gradually and reduces the likelihood of
pain to a minimum.
Research into the effectiveness of the WAND ® in reducing pain and behavioral
problems of children gives mixed results. Previous research by J. Versloot
showed the success of a computer-controlled anesthesia, but gave the
disadvantage of longer proceduretime. The Sleeper One is a new variant on the
market with a faster turnaround and a higher expected comfort.
Study objective
The aim of this study is to compare the pain and distress response of children
during the application of local anaesthesia injection using a computerized
device (the Wand ® or the Sleeper One®) and during the following dental
treatment.
Study design
The study is a prospective randomized cross- over model with two treatment
sessions in a patient whereby one of the two local anaesthesia techniques were
used.
Randomization of the techniques are performed by using a randomization list
generated by SPSS.
Intervention
The patient will get anesthesia with WAND ® or the Sleeper One ® method. Each
patient undergoes two operations in which one of the two stunning devices used
Study burden and risks
The children treated for caries at the center, always receive a local
anesthetia. Both systems are similar and used interchangeably. This research
provides only guidance to the choice of the anesthesia system.
louwesweg 1
1066 EA
NL
louwesweg 1
1066 EA
NL
Listed location countries
Age
Inclusion criteria
All subjects were referred to a pediatric dentistry practice by their home dentist. The subjects are selected based on the following criteria: age between 4 and 6 years, and at least two restorative treatments.
Exclusion criteria
no special needs education following, no communication problems
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL30999.029.10 |