Evaluation of the Anesthetic Efficacy of Intraosseous Anesthesia By Quicksleeper 5 computer-controlled system Versus inferior alveolar nerve Block in first Mandibular Molars with Irreversible Pulpitis.
Our aim is to evaluate the anesthetic efficacy of intraosseous anesthesia by Quicksleeper 5 computer controlled system versus inferior alveolar nerve block in first mandibular molars with irreversible pulpitis.
Design
In this clinical trial, 64 patients (32 males and 32 females) will participate and randomly receive one of two methods of anesthesia. Then the data will be divided into four groups based on age and anesthesia, the study is not blind
Settings and conduct
In this study, one of two different methods of anesthesia for patients who refer to the Department of Endodontics at Shahid Beheshti Dentistry School will be performed.
The operator (anesthetic injector) is one endodontist and different from the researcher; according to the limitations, only the statistical analyst will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: between 18 and 60 years old; patient satisfaction to enter the study; patients should have at least one first vital mandibular molar without spontaneous pain; the absence of periapical radiolucency or any periapical lesions in radiography; patients without any systemic diseases; absence of acute inflammation and advanced periodontal disease at the first mandibular molar and adjacent Molar and premolar teeth and injection area.
Exclusion criteria: lactate or pregnant women; any history of alergy to anesthetic solutions; using analgesic drugs since 12 hours before the treatment; severe dental pain that needs emergency treatment; non vital coronal pulp tissue; teeth with full crown; no pulp exposure after removing caries.
Intervention groups
For patients in two age groups (18 to 40 and 40 to 60 years old), anesthesia is performed randomly (intraosseous injection by Quicksleeper 5 and inferior alveolar nerve block).
Main outcome variables
Success of the anesthesia; onset and duration of anesthesia; pain; pulse
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180930041187N1
Registration date:2019-02-05, 1397/11/16
Registration timing:registered_while_recruiting
Last update:2019-02-05, 1397/11/16
Update count:0
Registration date
2019-02-05, 1397/11/16
Registrant information
Name
Saeed Gharibian bejestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2276 3836
Email address
saeed.gharibian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Anesthetic Efficacy of Intraosseous Anesthesia By Quicksleeper 5 computer-controlled system Versus inferior alveolar nerve Block in first Mandibular Molars with Irreversible Pulpitis.
Public title
Comparison of two methods of intraosseous injection and lower alveolar nerve block in the first mandibular molars with irreversible pulpitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the patient is over 18 years and under the age of 60 years
Patient Satisfaction to enter the study
Patients have the ability to read and understand the consent and sign it
Patients should have at least one first vital mandibular molar without spontaneous pain and positive response to Electrical Pulp Tester and prolonged response to the cold test
The absence of periapical radiolucency or any periapical lesions in radiography
Patients without any systemic diseases
Absence of acute inflammation and advanced periodontal disease at the first mandibular molar and adjacent Molar and premolar teeth and injection area
Exclusion criteria:
History of any cardiovascular disease and high blood pressure
Lactate or pregnant women
Any history of alergy to anesthetic solutions
Using analgesic drugs since 12 hours before the treatment
Mobility more than 0.5 mm
Probing more than 3 mm in mesial and distal
Severe dental pain that needs emergency treatment
Non vital coronal pulp tissue
Teeth with full crown
No lip numbness after the Inferior Alveolar Nerve Block injection
No pulp exposure after removing caries
lack of cooperation or interest of patient to continue the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals after obtaining consent to participate in this research are divided by stratified balanced block randomization method Into four groups (A, B, C and D) with 16 people in every group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Dental Research Institute, Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Dental School, Daneshjoo boulevard, Shahriari square, Velenjak
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2017-08-01, 1396/05/10
Ethics committee reference number
IR.SBMU.RIDS.REC.1396.504
Health conditions studied
1
Description of health condition studied
Asymptomatic irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Asymptomatic irreversible pulpitis
Primary outcomes
1
Description
Success of the Anesthesia
Timepoint
After the Injection and during root canal therapy (RCT)
Method of measurement
Vitality pulp test (Electrical pulp tester and endo ice) before RCT and questioning from patients during RCT
2
Description
Pain during injection
Timepoint
During injection of Anesthetic solution and immediately after completion of injection
Method of measurement
Heft-parker visual Analogue Scale
3
Description
Pain
Timepoint
Before injection (during vital pulp tests), after injection (during the evaluation of anesthesia success)
Method of measurement
Heft-parker visual Analogue Scale
4
Description
Pulse
Timepoint
Before injection , after injection
Method of measurement
Pulse-oximeter
5
Description
Onset of Anesthesia
Timepoint
After the injection with 1-minute intervals for a period of 15 minutes
Method of measurement
Vitality pulp test (pulp tester and endo ice)
6
Description
Duration of Anesthesia
Timepoint
From the beginning to the end of the treatment session
Method of measurement
Asking from the patients
Secondary outcomes
1
Description
anxiety
Timepoint
Before injection
Method of measurement
Visual Analogue Scale for Anxiety
Intervention groups
1
Description
Intervention group: For the first group (18 to 40 years old), Intraosseous injection technique would be used to achieve primary pulpal anesthesia using a QuickSleeper 5 device product by (Dental Hi Tec).
Category
Treatment - Other
2
Description
Intervention group: For the second group (40 to 60 years old), Intraosseous injection technique would be used to achieve primary pulpal anesthesia using a QuickSleeper 5 device product by (Dental Hi Tec).
Category
Treatment - Other
3
Description
Intervention group: For the third group (18 to 40 years old), inferior alveolar nerve block technique (conventional technique) would be used to achieve primary pulpal anesthesia.
Category
Treatment - Other
4
Description
Intervention group: For the fourth group (40 to 60 years old), inferior alveolar nerve block technique (conventional technique) would be used to achieve primary pulpal anesthesia.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Gharibian Bajestani
Street address
Dental school of Shahid Beheshti University of Medical Sciences , Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2240 3075
Email
DentalSchoolInfo@sbmu.ac.ir
Web page address
http://dentistry.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Dental school of Shahid Beheshti University of Medical Sciences , Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9780
Fax
+98 21 2243 9981
Email
Mpajouhesh@sbmu.ac.ir
Web page address
https://retech.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Student Researcher
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Gharibian bejestani
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 7,Mehr Ave., bostan dovom Street., Pasdaran Street., Tehran City
City
Tehran
Province
Tehran
Postal code
1664869593
Phone
+98 21 2276 3836
Fax
+98 21 2276 3839
Email
saeed.gharibian@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Shiva Shojaeian
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Endodontics
Street address
Dental school, Shahid Beheshti University,Daneshju Blv, Evin Blv, Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2240 3075
Email
shiva_sh84@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Gharibian Bejestani
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 7,Mehr Ave., bostan dovom Street., Pasdaran Street., Tehran City
City
Tehran
Province
Tehran
Postal code
1664869593
Phone
+98 21 2276 3836
Fax
+98 21 2276 3839
Email
saeed.gharibian@sbmu.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
All collected deidentified individual Participant Data.
When the data will become available and for how long
Starting 3 months after publication
To whom data/document is available
Available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
There is no limitation for what types of analyses will be used.
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.