Comparison the success of inferior alveolar nerve block with intraligament or buccal infiltration in mandibular first molar with symptomatic irriversible pulpitis : A randomized control clinical trial
Comparison the success of inferior alveolar nerve block with intraligaman or buccal infiltration in mamdibular first molar with symptomatic irriversible pulpitis
Design
Clinical trials with community based and pragmatic control group, with factorial groups, blinded and randomized
Settings and conduct
96 patients who referred to the Department of Endodontics of Tabriz Dental School, who had the criteria defined in the study and whose first mandibular molars were marked with irreversible pulpitis, were selected and divided into three groups of 32 according to the protocol of injection.
The groups will be coded to the statistical analyzer and the analyst is not aware of the type of technique. Anesthetizing by one person and providing an access cavity and recording pain will be done by another person. The pain recorder is not aware of the study technique.
Participants/Inclusion and exclusion criteria
Entry requirements: Systemically healthy patient؛ Subjects 18-65 years of age: No sensivity to epinephrin and articaine؛ No facial parastacidae؛ The patient with the 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 I: Injection of IANB (Inferior alveolar nerve block)
Group II: Injection of IANB + Buccal Infiltration
Group III: Injection of IANB + intra-ligament injection
Main outcome variables
The amount of pain the patient has
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101108005141N6
Registration date:2018-02-03, 1396/11/14
Registration timing:registered_while_recruiting
Last update:2018-02-03, 1396/11/14
Update count:0
Registration date
2018-02-03, 1396/11/14
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
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the success of inferior alveolar nerve block with intraligament or buccal infiltration in mandibular first molar with symptomatic irriversible pulpitis : A randomized control clinical trial
Public title
the success of inferior alveolar nerve block with intraligament or buccal infiltration in mandibular posterior teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Systemically healthy patient
Subjects 18-65 years of age
No sensivity to epinephrin and articaine
No facial parastacidae
Do not use any medication 6 hours before treatment
Not taking any medication that interferes with numbness
No pathoes in the areas of injection
Patient not to be pregnant
Absence of pathologic pockets during probing
The patient with the first molar with symptomatic irriversible pulpitis
Exclusion criteria:
Any illness that is unable to fill the informed consent form
history of trauma
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
96
Actual sample size reached:
96
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 three 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 48 (for male and female) as a code and sorted according to the numbers and the software will be randomized into three groups. The person who randomizes is not aware of how to study.
Blinding (investigator's opinion)
Double blinded
Blinding description
1. The groups will be coded to the statistical analyzer and the analyst is not aware of the type of technique.
2. Anesthetizing by one person and providing an access cavity and recording pain will be done by another person. The pain recorder is not 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 committee tabriz university of medical science
Street address
Floor3- Centeral Building No2-Tabriz University of Medical Sciences- Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2017-09-27, 1396/07/05
Ethics committee reference number
IR.TBZMED.REC.1396.462
Health conditions studied
1
Description of health condition studied
pulp disease
ICD-10 code
ICD-XI
ICD-10 code description
Diseases of pulp and periapical tissues
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
Use Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In the control group, standard block injection was performed using Articanin 4% solution (Artinibsa; Inibsa, Barcelona, Spain) with epinephrine 100000/1. After 15 minutes, the anesthetized teeth were isolated and the cavity was prepared and access prepration will be done.
Category
Treatment - Other
2
Description
Intervention group 1: Block standard injection is performed using Articaine 4% solution (Artinibsa; Inibsa, Barcelona, Spain) with an epinephrine of 100,000/1. 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
3
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 is injected and after 5 minutes the access cavity is prepared.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz university of medical science dentistry faculty
Full name of responsible person
Dr Shahriar Shahi
Street address
Floor3, Central Building No2, Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
Sshahriar32@gmail.com
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
Floor3, Centeral Building No.2, Tabriz University of Medical Sciences- Golgasht St
City
tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
sshahriar32@gmail.com
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
Periodontal and dental research center
Full name of responsible person
Dr shahriar shahi
Position
Professor of Endodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Floor3, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
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
Dr shahriar shahi
Position
Professor of Endodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Floor3, Central Building No2, Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
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
Floor3, central building No2, tabriz university of medical science, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
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