Efficacy and acceptance of a new local anesthesia technique (needleless injection) with the conventional technique in the management of maxillary deciduous teeth
Determining Efficacy and acceptance of a new local anesthesia technique (needleless injection) with the conventional technique in the management of maxillary deciduous teeth
Design
The study is a cross-over clinical trial of 30 children in need of restorative treatments in maxillary primary molars using a standard needle-less injection technique and a randomized, double-blinded study.
Settings and conduct
This study, which is carried out in the pediatric ward of Campus of Tehran Dental School, in each case, one new molar tooth is anesthetized by the new method and the other one is anesthetized by the conventional method.
Participants/Inclusion and exclusion criteria
Inclusion criteria Children aged 6 to 12 years with decayed primary molar on both sides of the maxilla who need anesthesia repair and their parents are satisfied after studying the consent form. The exclusion criteria are children who are so uncooperative that the university refuses to accept them, as well as children who have any systemic, infectious or viral illness.
Intervention groups
In this study, the efficacy and acceptability of anesthesia was evaluated by a new (needle-free) method. In one primary molars, this method was used for anesthesia and in the other primary molars, the most common anesthesia was used.
Efficacy and acceptance of a new local anesthesia technique (needleless injection) with the conventional technique in the management of maxillary deciduous teeth
Public title
Comparison of the efficacy of non-needle and needle anesthesia (common dental anesthesia)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 6 to 12 years.
These children have decayed primary molar on both sides of the maxilla.
These decayed primary molars require restorative treatment.
The repair of these decayed primary molars requires anesthesia.
Exclusion criteria:
children who are so uncooperative that the university refuses to accept them.
Children who have any systemic or infectious or viral diseases.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Sample size
Target sample size:
25
More than 1 sample in each individual
Number of samples in each individual:
2
Two decayed primary molars in the maxilla, each anesthetized with two separate treatment sessions.
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization process in this study is a quadruple block design. In this way, we have four modes for intervention, including the left maxillary anesthesia needle / left maxillary anesthesia needle / right maxilla anesthesia needleless needle / right maxilla anesthesia needle needle. These four options are placed in separate envelopes in a package and placed in the first session of the intervention in front of the child and are randomly selected by the child and given to the practitioner and the intervention is performed. The second session is on the opposite side and the second method is done.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study the supervisor does the injection and during the injection the FLACC questionnaire is filled by the secretary who has no information about the dental work and the type of anesthesia, so this person is blind. Also, the student doing the restoration work (which is the same student working on this thesis) will be blind because he does not know in what way the child is numb.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Dentistry, University of Tehran
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
tehran
Province
Tehran
Postal code
1467664961
Approval date
2019-07-29, 1398/05/07
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1398.085
Health conditions studied
1
Description of health condition studied
Efficacy and acceptance of a new local anesthesia technique (needleless injection)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The pain and discomfort questionnaire (FLACC) is rated as 3 (0 1 2) as to whether the condition (face / legs / child activity / crying during injection and child sympathy).
Timepoint
The FLACC questionnaire is filled in at the time of anesthesia injection and during the regenerative treatment.
Method of measurement
The pain and discomfort questionnaire (FLACC) is rated as 3 (0 1 2) as to whether the condition (face / legs / child activity / crying during injection and child sympathy).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group is a group that is anesthetized with a needleless anesthesia. In this method, a compression anesthesia device called Madajet is used, which does not have a needle and can be sterilized. Milk Spray, which each time sprays 0.1 ml of anesthetic into a small area of tissue (the only area we want to anesthetize), which is lent to a needle because of its jet depth. Anesthesia is injected at three points: the mesococcal / distal buccal and palatal.
Category
Treatment - Devices
2
Description
Control group: Control group: There are groups that are anesthetized with the usual anesthetic. The usual injection of anesthesia with a needle is as follows: The anesthetic is injected with a sterile syringe and the needle (which is available in different gauges) is injected deep into the vestibule. Lidocaine anesthesia is 2% and epinephrine is 1 in 80,000 for the drug distribution company.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran university of medical sciences
Full name of responsible person
Ghazaleh Baniebrahimi
Street address
Khani Abadno - Shariati Town - Mahan Street - Opposite Shariati Park - International Campus Dental School
City
Tehran
Province
Tehran
Postal code
1696617814
Phone
+98 21 5585 1131
Email
ghazalebaniebrahimi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ghazaleh Baniebrahimi
Street address
Faculty of Dentistry, Shahid Zolfi St. (Mahan), Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1696617814
Phone
+98 21 5585 1151
Email
ghazalebaniebrahimi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghazaleh Baniebrahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Complex Golchin Laleh 60 Ave Laleh Alley Aqdessia South Golchin
City
tehran
Province
Tehran
Postal code
1696617814
Phone
+98 21 2248 8305
Email
ghazalebaniebrahimi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghazaleh Baniebrahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golchin Laleh complex 60 Ave Laleh Alley South Golchin Aqdessia
City
tehran
Province
Tehran
Postal code
1696617814
Phone
+98 21 2248 8305
Email
ghazalebaniebrahimi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghazaleh Baniebrahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Aqdessia South Golchin Ave Laleh Alley Golchin Laleh complex 60
City
Tehran
Province
Tehran
Postal code
1696617814
Phone
+98 21 2248 8305
Email
ghazalebaniebrahimi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All potential data is shared after unidentifiable people.
When the data will become available and for how long
Start of access period from 1399
To whom data/document is available
All applicants
Under which criteria data/document could be used
Can be used in all situations.
From where data/document is obtainable
Tehran University of Medical Sciences
What processes are involved for a request to access data/document