Comparison of inferior alveolar nerve block success rate in mandible in Halsted technique and "Water On Tray" technique in the patients referred to the dental clinic.
The aim of this study is investigating the efficiency of "Water on tray" (WOT) technique in comparison with Halsted technique
Design
The clinical trial has a control group, Single-blinded in two 45-member groups, Randomize through the coin tossing. (Lion will be Halsted and Line will be WOT)
Settings and conduct
The referred patients to Dental Clinic of IB-GUMS are categorized in one of the injection group blindly with their consent, while they have inclusions criteria. The methods which are compared in the study are Halsted and "Water On Tray"
Participants/Inclusion and exclusion criteria
The patients who need the dental treatment in the mandible which both categorized in ASA I and acute pain is not their chief complaint.
Intervention groups
In the interventional group, "Water On Tray" injection with a bent needle create an approximate perpendicular accessibility surface on the medial surface of the ramus. The tip of the needle remains in contact with the bone, during the injection.The needle`s bevel prevents subperiosteal injection.
In the control group, Halsted method conducts according to the Malamed SF. Handbook of local anesthesia. 6th ed-2013.
Main outcome variables
The rate of pain felt during the injection and the rate of numbness in WOT technique in compare with Halsted technique.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171219037960N1
Registration date:2018-04-22, 1397/02/02
Registration timing:retrospective
Last update:2018-04-22, 1397/02/02
Update count:0
Registration date
2018-04-22, 1397/02/02
Registrant information
Name
Seyed Hadi Hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3348 6421
Email address
drhadihoseini@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2017-11-26, 1396/09/05
Actual recruitment end date
2017-12-21, 1396/09/30
Trial completion date
empty
Scientific title
Comparison of inferior alveolar nerve block success rate in mandible in Halsted technique and "Water On Tray" technique in the patients referred to the dental clinic.
Public title
Evaluation of the "Water On Tray" anesthetic technique efficacy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients which need the dental treatment in mandible
All of the subjects of this study are in ASA I classification.
All of the subjects must have the vital first mandibular premolar in the side of injection, in order to conducted electric pulp test.
Exclusion criteria:
Certain noncardiovascular disease (e.g., thyroid dysfunction, diabetes, sulfite sensitivity).
Consuming MAO inhibitors
Consuming of Tricyclic Antidepressant
Consuming of Phenothiazines
The subjects who state the acute pain as the chief complaint throughout history
Age
From 15 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
90
Actual sample size reached:
85
More than 1 sample in each individual
Actual sample size in each individual:
2
The first inferior alveolar nerve block injection in a side of the subject.
Randomization (investigator's opinion)
Randomized
Randomization description
Each of the subjects, if they have inclusion criteria, will enter in one the injection groups via the result of the coin toss(Lion will be Halsted and Line will be WOT)
Blinding (investigator's opinion)
Single blinded
Blinding description
After receiving consent, all surveyors are informed that they are likely categorized in the studied group randomly, with considering the fact that no excessive danger exists and only the injection method is different.
Placebo
Not used
Assignment
Parallel
Other design features
In Water On Tray technique, because of the bent needle to 90 degrees and the possibility of approximate perpendicular injection, while the bone contact remains, The Halsted problem solved.The main idea and the name of this technique are adapted from the liquids nature, spreading on a surface-once they pour; on the other words, the anesthetic solution spreads on the ramus surface after injection and deliver to the inferior alveolar nerve and the lingual nerve.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
across from the 17th Shahrivar Hospital-Shahid Siadati St-Namjou St.
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2017-11-25, 1396/09/04
Ethics committee reference number
IR.GUMS.REC.1396.329
Health conditions studied
1
Description of health condition studied
The comparison of inferior alveolar nerve block success rate in mandible in Halsted technique and Water ON Tray technique
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The rate of the inferior alveolar nerve block in the first injection via Water On Tray technique.
Timepoint
The numbness evaluation conducts every 30 seconds after 2 minutes.
Method of measurement
We ask the subjects about the lack of feeling the stick test (Dental explorer for extraoral evaluation and the 25 gauge needle for intraoral), then the moment record as the numbness time in the minute unite.
Secondary outcomes
1
Description
The pain rate during the injection
Timepoint
After injection
Method of measurement
Asking the patient according to Numeric Scale Rate of pain
Intervention groups
1
Description
Intervention group: In this group, we conduct the inferior alveolar nerve block with the long needle (25mm, gauge 27) which bent by own cap (to achieve an approximate perpendicular surface on the medial surface of the ramus) Also, the tip of the needle remains the contact to the bone, during the injection. The main idea and the name of the technique are adapted from the liquids nature, which spread on a board as soon as the pour; In this technique, the anesthetic solution will spread on the ramus surface after injection and receive to the inferior alveolar nerve and the lingual nerve. The used cartridge contains 2% lidocaine with 1:80000 epinephrine.
Category
Treatment - Other
2
Description
Control group: The control group undergoes Halsted technique, according to the method which mentioned in Malamed SF. Handbook of local anesthesia. 6th ed-2013. In this method, the needle is straight and doesn`t contact bone during injection. In this group, like the interventional group, we use the long needle (25mm, gauge 27) and the cartridge contains 2% lidocaine and 1:80000 epinephrine.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The Dental Clinicl of International Branch of Guilan University of Medical Sciences
Full name of responsible person
Heidar Mahmoudi Chenari
Street address
30 Metery Blvd
City
Bandar`e Anzali
Province
Guilan
Postal code
43146-37758
Phone
+98 13 4455 3185
Fax
+98 13 4455 3184
Email
ib@gums.ac.ir
Web page address
http://www.gums.ac.ir/ib
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The dental clinic of the International Branch of Guilan University of Medical Sciences (IB-GUMS)
Full name of responsible person
Heidar Mahmoudi Chenari
Street address
30 Metery Blvd
City
Bandar`e Anzali
Province
Guilan
Postal code
43146-37758
Phone
+98 13 4455 3185
Fax
+98 13 4455 3184
Email
ib@gums.ac.ir
Web page address
http://www.gums.ac.ir/ib
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The dental clinic of the International Branch of Guilan University of Medical Sciences (IB-GUMS)
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
Rasht University of Medical Sciences
Full name of responsible person
Seyed Hadi Hoseini
Position
Associate professor of Guilan University of Medical Sciences-Dentistry Faculty
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Fouman - Saravan Rd
City
Rasht
Province
Guilan
Postal code
41941-73774
Phone
+98 13 3348 6406
Fax
+98 13 3348 6423
Email
drhadihoseini@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyed Hadi Hoseini
Position
Associate professor of Guilan University of Medical Sciences-Dentistry Faculty
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Fouman - Saravan Rd
City
Rasht
Province
Guilan
Postal code
41941-73774
Phone
+98 13 3348 6406
Fax
+98 13 3348 6423
Email
drhadihoseini@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyed Hadi Hoseini
Position
Associate professor of Guilan University of Medical Sciences-Dentistry Faculty
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Fouman - Saravan Rd
City
Rasht
Province
Guilan
Postal code
41941-73774
Phone
+98 13 3348 6406
Fax
+98 13 3348 6423
Email
drhadihoseini@gums.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The subjects are coded and just the data will present to the investigators.
When the data will become available and for how long
6 month after publication
To whom data/document is available
The Universities of medical sciences and valid research organizations
Under which criteria data/document could be used
Repeat the research project in the other place or the other situation or complete the project.
From where data/document is obtainable
Via the chief investigator`s email
What processes are involved for a request to access data/document
Via organizational email and present the documents based on investigation in official organization