Aneasthetic success of Articaine\Epinephrine with combination of Mannitol in comparison with Articaine\Epinephrine for inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: A randomized controlled clinical trial
Aneasthetic success of Articaine\Epinephrine with combination of Mannitol in comparison with Articaine\Epinephrine for inferior alveolar nerve block in patients with symptomatic irreversible pulpitis
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
This study will be done on 124 patients who will be referred to the Department of Endodontics of Tabriz University of Medical Sciences. The patients who will have the inclusion criterias that explained in the study and also have the first mandibular molars with irreversible pulpitis, will be selected. They will be randomly divided into two groups (n=62 in each group) according to the protocol of injection. The groups will be coded and presented to the statistical analyzer and the analyst wont be aware of the type of injection. One person will do injection and another one will provide an access cavity and record pain. The pain recorder wont be aware of the technique of injectin.
Participants/Inclusion and exclusion criteria
inclusion criteria: Systemically healthy patients; Subjects 18-65 years of age; patients with no sensivity to Mannitol; The patients with mandibular first molar with symptomatic irriversible pulpitis.
exclusion criteria: Teeth with periradicular pathosis; patients with no respone to cold testing.
Intervention groups
Group one received IANB by using 1.8 mL Articaine with 1:200000 Epinephrine.
Group two received IANB by using 3-ml formulation of 1.9 ml Articaine with 1:200000 epinephrine plus 1.1 mL of 0.5 mol/L Mannitol.
Main outcome variables
The patient's pain degree
General information
Reason for update
Acronym
IANB
IRCT registration information
IRCT registration number:IRCT20180228038901N1
Registration date:2018-04-30, 1397/02/10
Registration timing:retrospective
Last update:2018-04-30, 1397/02/10
Update count:0
Registration date
2018-04-30, 1397/02/10
Registrant information
Name
sahar shakouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5965
Email address
shakoueis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
2017-01-04, 1395/10/15
Actual recruitment end date
2018-03-12, 1396/12/21
Trial completion date
empty
Scientific title
Aneasthetic success of Articaine\Epinephrine with combination of Mannitol in comparison with Articaine\Epinephrine for inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: A randomized controlled clinical trial
Public title
Efficacy of Mannitol on the success rate of anesthesia in mandibular posterior teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients without relevant medical conditions
patients older than 18
Patients not taking beta-blockers
patients not being medicated with any opioids preoperatively
patients without drug abusing
No pregnant or nursing mothers
Those without a contraindication for the use of Mannitol
Those known not to be allergic to one of the study medications
Those without orofacial infection
Exclusion criteria:
subjects with negative response to cold testing
Teeth with periradicular disease(unlike a widened periodontal ligament)
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
124
Actual sample size reached:
124
Randomization (investigator's opinion)
Randomized
Randomization description
We will have 62 patients in each group (31 women and 31 men) who will be randomly assigned into two groups. The randomization unit will be individual and the randomization tool will be Randlist software. Each patient entering the study will be assigned a number from 1 to 62 (for male and female) as a special code and they will be randomly put into two groups according to sorted numbers which will be set by software. The person who will randomize will not be aware of how to study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Pulp condition realizing tests and injection by one person and providing an access cavity and recording pain will be done by another person.Groups data will be coded and reported as A,B to analyzer,so the analyzer and pain recorder are not aware of the study technique.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee 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
2018-03-12, 1396/12/21
Ethics committee reference number
IR.TBZMED.REC.1396.1269
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 Articaine 4% solution(DENTACAIN,Exir,Iran ) will be done . After 15 minutes of block anesthesia and numbness of the lips, the teeth will be isolated and the access cavity will be done.
Category
Treatment - Other
2
Description
Intervention group 2: under sterile conditions, 1.9 mL of 4% Articaine with 1:200,000 epinephrine will be drawn from standard dental cartridges (DENTACAIN,Exir,Tehran,Iran) into a sterile 3-mL Luer-Lok disposable syringe (AVA,Tehran.,Iran). 1.1 mL of 0.5 mol/L mannitol will be added to this syringe, which will be withdrawn from a 500-mL solution of a 20% supersaturated mannitol solution (American Regent Laboratories, Inc, Shirley, NY) by using a sterile disposable syringe.To mixing the solution the combined Articaine/mannitol formulation in the syringe will be then inverted 20 times.Before the mannitol be added to the syringe containing the Articaine with epinephrine, the 50- mL vial will be heated in a water bath (Teledyne Hanau, Buffalo, NY) to 80_C for 15 minutes to remove any crystals present in the supersaturated solution .A standard IAN block will be done by using a 27-gauge, 1½-inch needle (AVA,Tehran,Iran), enclosed to the Luer-Lok syringe
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Sahar Shakouei
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
sshakouie@hotmail.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
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
sshakouie@hotmail.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
Dental and Periodontal Research Center
Full name of responsible person
Sahar Shakouei
Position
Associate 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
sshakouie@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Dentistry
Full name of responsible person
Sahar Shakouei
Position
َAssociate 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
sshakouie@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Dentistry
Full name of responsible person
Sahar Shakouei
Position
Associate 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
sshakouie@hotmail.com
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