Evaluation of analgesia and anxiety amount due to mandibular nerve block via QuickSleeper in primary mandibular molar teeth pulp therapy of children aged 6 to 8 years
Evaluation of analgesia and anxiety amount due to mandibular nerve block via QuickSleeper in pulp therapy of primary mandibular molar teeth of children aged 6 to 8 years
Design
Twenty eligible children aged 6 to 8 with the need of vital pulp therapy on the both sides of the mandible (40 teeth) that referred to pediatric department of Shahid Sadoughi Dental school of yazd are selected.
Settings and conduct
This study is a randomized clinical trial study. At the first session the injection has done randomly by one of the anesthetic method (block or intraosseous technique) and after 7 to 21 days, the same tooth at the opposite side of the mandible done by another method. Patients' pain and anxiety during injection and treatment is measured by Visual Analog Scale and Venham picture test, Venham anxiety score, pulse oximeter respectively.
Participants/Inclusion and exclusion criteria
Children aged 6 to 8 with the need of vital pulp therapy on the primary molars in both sides of the mandible.
Intervention groups
At the first session the injection has done randeomly by one of the anesthesic method (block or intrabone technique) and after 7 to 21 days, the same tooth at the opposite side of the mandible done by another method.
Main outcome variables
Analgesia and anxiety amount due to mandibular nerve block via QuickSleeper
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171013036745N1
Registration date:2018-01-04, 1396/10/14
Registration timing:registered_while_recruiting
Last update:2018-01-04, 1396/10/14
Update count:0
Registration date
2018-01-04, 1396/10/14
Registrant information
Name
fatemeh kebriaee
Name of organization / entity
Dental Faculty, ShahidSadoughiuniversity of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 35362558814
Email address
f.kebriaee@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of analgesia and anxiety amount due to mandibular nerve block via QuickSleeper in primary mandibular molar teeth pulp therapy of children aged 6 to 8 years
Public title
The effect of intra-bone injection in reducing pain and anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
( Children without systemic disease (disability, autism, cancer, heart disease, sickle cell anemia, etc.) ; Children whose score according to modified Venham behaviore scale is less than 3 ; Patients who have not used analgesics within 48 hours before treatment ; Children needing vital pulp therapy on similar primary molars in both sides of the mandible (with clinical and radiological confirmation) ; Parental and patient consent ; Parental and patient consent )
Exclusion criteria:
( Children who do not attend the second treatment session ; Children with necrosis teeth )
Age
From 6 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Vital pulp therapy on similar primary molars in both sides of the mandible
Randomization (investigator's opinion)
Randomized
Randomization description
simple individual randomization by table of random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Shahid Sadoughi University of Medical Sciences Yazd
Street address
Shahid Bahonar Square, Central Organization of Shahid Sadoughi University of Medical Sciences, Yazd
What processes are involved for a request to access data/document
The applicant sends a request by sending an e-mail to the above-mentioned email; after reviewing his/her request, the data file will be sent to him/her within a maximum of one month