Comparison of the success rate of different anesthesia protocols in mandibular first molars with symptomatic irreversible pulpitis using prilocain local anesthesia : A randomized control clinical trial
Comparison of the success rate of different anesthesia protocols in mandibular first molars with symptomatic irreversible pulpitis using prilocain anesthetic agent: A randomized control clinical trial
Design
Clinical trial with control group, community based and pragmatic, factorial group, double blinded, randomized
Settings and conduct
128 patients who will be referred to the Department of Endodontics of Tabriz dental faculty, who meet the inclusion criteria and who with irreversible pulpitis in first mandibular molars, will be selected and divided into four groups of 32 patients according to the protocol of injection. The groups will be coded and presented to the statistical analyzer. The analyst will not be aware of the type of technique. Anesthesia and providing an access cavity and recording pain will be done by different persons. The pain recorder will not be aware of the study technique.
Participants/Inclusion and exclusion criteria
Entry requirements: Systemically healthy patient؛ Subjects 18-65 years of age؛ No sensivity to prilocaine؛ No facial parastesia؛ The patient with mandibular first molar with symptomatic irriversible pulpitis. Conditions of failure to enter: Any illness that is unable to fill the informed consent form؛ Lack of vital tissue in the pulp chamber during access cavity preparation
Intervention groups
Group 1: Injection of IANB(Inferior alveolar nerve block)
Group 2: Injection of IANB technique + intraligament injection
Group 3:Injection of IANB + Buccal infiltration
Group 4: Two injection of standard IANB
Main outcome variables
The amount of pain the patient has
General information
Reason for update
Acronym
IANB
IRCT registration information
IRCT registration number:IRCT20101108005141N7
Registration date:2018-04-04, 1397/01/15
Registration timing:retrospective
Last update:2018-04-04, 1397/01/15
Update count:0
Registration date
2018-04-04, 1397/01/15
Registrant information
Name
Shahriar Shahi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41133559659
Email address
shahis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-09, 1396/10/19
Expected recruitment end date
2018-06-10, 1397/03/20
Actual recruitment start date
2016-11-30, 1395/09/10
Actual recruitment end date
2017-11-04, 1396/08/13
Trial completion date
empty
Scientific title
Comparison of the success rate of different anesthesia protocols in mandibular first molars with symptomatic irreversible pulpitis using prilocain local anesthesia : A randomized control clinical trial
Public title
The success rate of different anesthesia protocols in mandibular posterior teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects 18-65 years of age
No sensitivity to anesthetic agent
No facial parasthesia
Do not use of any narcotic drug 6 hours before treatment
Patient not to be pregnancy
No history of truma
Absence of pathologic pockets during probing
Patient with mandibular first molar with symptomatic irriversible pulpitis
Normal view of teeth in periapical region
Exclusion criteria:
Any patients have not inclusion criteria
Any illness that is unable to fill the informed consent form
Absence of vital pulp tissue in access cavity
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
128
Actual sample size reached:
128
Randomization (investigator's opinion)
Randomized
Randomization description
We will have 32 patients in each group (16 women and 16 men) who will be randomly assigned into four groups. The randomization unit is individual. A randomization tool will be performed with the Randlist software (each patient entering the study will be assigned a number from 1 to 64 (for male and female) as a code and according to the arrenged numbers in the software will be randomized into four groups. The person who randomizes wont be aware of how to study.
Blinding (investigator's opinion)
Double blinded
Blinding description
1. The groups will be coded and presented to the statistical analyzer and the analyst wont be aware of the type of technique.
2. Anesthetizing will be done by one person and providing an access cavity and recording pain will be done by another person. The pain recorder wont be aware of the study technique.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Tabriz University of Medical Sciences
Street address
3rd floor, No2 Centeral Building , Tabriz University of Medical Sciences, ,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2017-09-30, 1396/07/08
Ethics committee reference number
IR.TBZMED.REC.1396.1076
Health conditions studied
1
Description of health condition studied
Symptomatic irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
The amount of pain
Timepoint
During access cavity preparation and entrance in to the pulp chamber and the root canal
Method of measurement
Using Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1:IANB(Inferior alveolar nerve block) standard injection using prilocaine 3% solution (Prilocaine, Felypressin 0.03 IU/Darou Pakhsh,Iran ) will be done . After 15 minutes of block anesthesia and numbness of the lips, an infiltration on the buccal side of the affected tooth will be performed at a rate of 0.5 ml with a normal syringe with 27 gauge needle. After 5 minutes, the teeth will be isolated and the access cavity will be done.
Category
Treatment - Other
2
Description
Intervention group 2: After IANB injection and 15 minute timeout and anesthesia of the lips, intra-ligament injection with a special injection syringe and a short needle with 27 gauge will be done.Then, in the mesial and distal teeth, 0.2 ml of the solution will be injected and after 5 minutes the access cavity will be prepared.
Category
Treatment - Other
3
Description
Intervention group 3:After IANB injection and 15 minute timeout and anesthesia of the lips, second IANB injection will be done.and after 5 minutes the access cavity will be prepared.
Category
Treatment - Other
4
Description
Control group:In the control group, standard block injection using Prilocaine 3% solution (Prilocaine, Felypressin 0.03 IU/Darou Pakhsh,Iran) will be done . After 15 minutes and anesthesia of the lips, teeth will be isolated and access prepration will be done.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Shahriar Shahi
Street address
3rd floor, No 2 Central Building , Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
+98 41 3334 6977
Email
sshahriar32@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Prof. Abolghasem Jouyban
Street address
3rd floor, No. 2 Central Building , Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5365
Fax
+98 41 3334 6977
Email
sshahriar32@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz 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
Dental and Periodontal Research Center
Full name of responsible person
Shahriar Shahi
Position
Professor of Endodontics
Latest degree
Specialist
Other areas of specialty/work
Endodontics
Street address
3rd floor, No. 2 Cental Building ,Tabriz University of Medical Science,Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
+98 41 3334 6977
Email
sshahriar32@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Dentistry
Full name of responsible person
Shahriar Shahi
Position
Professor of Endodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
3rd floor, No2 Central Building , Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
+98 41 3334 6977
Email
sshahriar32@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shahriar Shahi
Position
Professor of Endodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
3rd floor, No.2 Central Building , Tabriz University of Medical Science, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
+98 41 3334 6977
Email
sshshriar32@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
No - There is not 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