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General information
We have to inject another anesthetic solution.
Allergies to local anesthetics and sulfites
Pregnant women
Taking any medication 6 hours before referral
Having Systemic Disease
We have to inject another anesthetic solution.
Allergies to local anesthetics and sulfites
Pregnant women
Taking any medication 6 hours before referral
Having Systemic Disease
The widening of periodontal ligament space
The presence of a periapical radiolucency
We have to inject another anesthetic solution. Allergies to local anesthetics and sulfites Pregnant women Taking any medication 6 hours before referral Having Systemic Disease The widening of periodontal ligament space The presence of a periapical radiolucency
مجبور باشیم محلول بی حسی دیگری تزریق کنیم.
آلرژی به بی حسی های موضعی و سولفیت ها
خانم های باردار
مصرف هر گونه دارو 6 ساعت قبل از مراجعه بیمار
دارای بیماری سیستمیک
مجبور باشیم محلول بی حسی دیگری تزریق کنیم.
آلرژی به بی حسی های موضعی و سولفیت ها
خانم های باردار
مصرف هر گونه دارو 6 ساعت قبل از مراجعه بیمار
دارای بیماری سیستمیک
گشاد شدن فضای لیگامان پریودنتال
وجود رادیولوسنسی پری آپیکال
مجبور باشیم محلول بی حسی دیگری تزریق کنیم. آلرژی به بی حسی های موضعی و سولفیت ها خانم های باردار مصرف هر گونه دارو 6 ساعت قبل از مراجعه بیمار دارای بیماری سیستمیک گشاد شدن فضای لیگامان پریودنتال وجود رادیولوسنسی پری آپیکال
Recruitment centers
#1
Name of recruitment center - English: Dental Clinic
Name of recruitment center - Persian: کلینیک آموزشی دندانپزشکی
Full name of responsible person - English: Barzin Ali
Full name of responsible person - Persian: محمد برزین
Street address - English: Motahari Boulevard
Street address - Persian: بلوار مطهری
City - English: Yasuj
City - Persian: یاسوج
Province: Kohgilouyeh-va-Boyrahmad
Country: Iran (Islamic Republic of)
Postal code: 75919-54661
Phone: +98 74 3322 8274
Fax:
Email: saeide.jafari73@gmail.com
Web page address:
Name of recruitment center - English: Dental Clinic
Name of recruitment center - Persian: کلینیک آموزشی دندانپزشکی
Full name of responsible person - English: Ali Barzin
Full name of responsible person - Persian: علی برزین
Street address - English: Next to the Blood Transfusion Organization, Motahari Boulevard
Street address - Persian: بلوار مطهری،جنب سازمان انتقال خون
City - English: Yasuj
City - Persian: یاسوج
Province: Kohgilouyeh-va-Boyrahmad
Country: Iran (Islamic Republic of)
Postal code: 75919-54661
Phone: +98 74 3322 8274
Fax:
Email: mohammad.layegh@yums.ac.ir
Web page address:
Name of recruitment center - English: Dental Clinic Name of recruitment center - Persian: کلینیک آموزشی دندانپزشکی Full name of responsible person - English: Ali Barzin Ali Full name of responsible person - Persian: محمدعلی برزین Street address - English: Next to the Blood Transfusion Organization, Motahari Boulevard Street address - Persian: بلوار مطهری،جنب سازمان انتقال خون City - English: Yasuj City - Persian: یاسوج Province: Kohgilouyeh-va-Boyrahmad Country: Iran (Islamic Republic of) Postal code: 75919-54661 Phone: +98 74 3322 8274 Fax: Email: saeide.jafari73mohammad.layegh@gmail.comyums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Oryad Hoseinmari
Full name of responsible person - Persian: حسین ماری اوریاد
Street address - English: Vice Chancellor for Research, University of Medical Sciences, Motahhari Blvd
Street address - Persian: بلوار مطهری، دانشگاه علوم پزشکی، معاونت پژوهشی
City - English: Yasuj
City - Persian: یاسوج
Province: Kohgilouyeh-va-Boyrahmad
Country: Iran (Islamic Republic of)
Postal code: 7591817719
Phone: +98 74 3334 6078
Fax: +98 74 3334 6079
Email: saeide.jafari73@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hosein Oryad
Full name of responsible person - Persian: حسین اوریاد
Street address - English: Vice Chancellor for Research, Yasouj University of Medical Sciences, Motahhari Blvd
Street address - Persian: بلوار مطهری، دانشگاه علوم پزشکی یاسوج، معاونت پژوهشی
City - English: Yasuj
City - Persian: یاسوج
Province: Kohgilouyeh-va-Boyrahmad
Country: Iran (Islamic Republic of)
Postal code: 7481374129
Phone: +98 74 3334 6078
Fax: +98 74 3334 6079
Email: en@yums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Hosein Oryad Hoseinmari Full name of responsible person - Persian: حسین ماری اوریاد Street address - English: Vice Chancellor for Research, Yasouj University of Medical Sciences, Motahhari Blvd Street address - Persian: بلوار مطهری، دانشگاه علوم پزشکی یاسوج، معاونت پژوهشی City - English: Yasuj City - Persian: یاسوج Province: Kohgilouyeh-va-Boyrahmad Country: Iran (Islamic Republic of) Postal code: 75918177197481374129 Phone: +98 74 3334 6078 Fax: +98 74 3334 6079 Email: saeide.jafari73en@gmail.comyums.ac.ir Web page address:
Protocol summary
Study aim
Comparison of the efficacy of 2% lidocaine anesthesia with epinephrine 1/ 100,000 and 3% mepivacaine in maxillary premolars with irreversible pulpitis
Design
Clinical trial with intervention and control group, prospective, randomized, double blinded, with a sample size of 76 patients
Settings and conduct
This study is done in a dental clinic. Before treatment, patients are given an explanation for the current research, and after receiving the necessary information, patients are given written consent for treatment. Patient treatment is done in a single session by a specific dentist. Encoding and giving anesthetic Carpools is done by one of the secretaries. After 7 minutes of injection of anesthetic solution, access to the endodontic cavity begins. Patient and the dentist are not aware of injactable solution. During accessing the endodontic cavity, the VAS chart is used to measure patient pain.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The presence of maxillary premolars with irreversible pulpitis, People aged 18 to 65
Exclusion criteria:
We have to inject another anesthetic solution, Allergies to local anesthetics and sulfites, Pregnant women, Taking any medication 6 hours before referral, Having Systemic Disease
Intervention groups
Intervention group: 1.8 ml of 3% mipivacaine ( Novocol Pharmaceutical of Canada Inc.) is injected with the infiltration technique to the maxillary premolars.
Control group: 1.8 ml of 2% lidocaine with 1/100,000 epinephrine (Tehran Darou Pakhsh Pharmaceutical Mfg.Co.) is injected with the infiltration technique to the maxillary premolars.
Main outcome variables
Patient pain during treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180818040824N1
Registration date:2018-10-30, 1397/08/08
Registration timing:retrospective
Last update:2018-11-25, 1397/09/04
Update count:1
Registration date
2018-10-30, 1397/08/08
Registrant information
Name
Saeide Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5357 3693
Email address
mohammad.layegh@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
2018-02-20, 1396/12/01
Actual recruitment end date
2018-07-21, 1397/04/30
Trial completion date
2018-08-05, 1397/05/14
Scientific title
Comparison of anesthetic efficacy of 2% lidocaine with 1/100000 epinephrine and 3% mepivacaine in premolars of maxilla with irreversible pulpitis
Public title
Comparison of anesthetic efficacy of 2% lidocaine and 3% mepivacaine in premolars of maxilla with irreversible pulpitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of maxillary premolars with irreversible pulpitis
People aged 18 to 65
Exclusion criteria:
We have to inject another anesthetic solution.
Allergies to local anesthetics and sulfites
Pregnant women
Taking any medication 6 hours before referral
Having Systemic Disease
The widening of periodontal ligament space
The presence of a periapical radiolucency
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
76
Actual sample size reached:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Those who have entered the study are randomly assigned to one of the two intervention and control groups in the random numbers table. Making random sequences is such that the even numbers and the odd numbers associated with the lidocaine group and the mepivacaine group respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
76 carpools (38 carpools containing 2% lidocaine with 1 /100,000 epinephrine and 38 carpools containing 3% mepivacaine ) are covered with paper and the codes A and B are inserted on it. The purpose is that the patient and the dentist is not aware of anesthetized injections, encoding is done by one of the secretaries.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasouj University of Medical Sciences
Street address
No. 17, Subsidiary A, Imam Hossein Town
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591817719
Approval date
2018-01-06, 1396/10/16
Ethics committee reference number
IR.YUMS.REC.1396.152
Health conditions studied
1
Description of health condition studied
Anesthetizing the teeth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patient pain during treatment
Timepoint
While providing access cavity
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Infusion of buccal infiltration one cartridge (1.8 ml) local 3% mepivacaine anesthetic solution, manufactured by the Canadian Novocol
Category
Treatment - Drugs
2
Description
Control group: Infusion of buccal infiltration one cartridge (1.8 ml) local anesthetic 2% Lidocaine with 1/100,000 epinephrine, manufactured by Tehran Darou pakhsh
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic
Full name of responsible person
Ali Barzin
Street address
Next to the Blood Transfusion Organization, Motahari Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-54661
Phone
+98 74 3322 8274
Email
mohammad.layegh@yums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hosein Oryad
Street address
Vice Chancellor for Research, Yasouj University of Medical Sciences, Motahhari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7481374129
Phone
+98 74 3334 6078
Fax
+98 74 3334 6079
Email
en@yums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Saeide Jafari
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 17, Western Suburbs, Imam Hossein Town
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591817719
Phone
+98 74 3333 5199
Email
saeide.jafari73@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammadkarim Layeghnezhad
Position
Faculty Dentist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dr Layeghnezhad Dental Office, Hejrat 2nd Street, Ferdowsi Avenue
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591796987
Phone
+98 74 3322 4635
Email
mohammad.layegh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Saeide Jafari
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 17, Shahid Fazli Alley, Imam Hossein Town
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591817719
Phone
+98 74 3333 5199
Email
saeide.jafari73@gmail.com
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
No - There is not 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
Data include patient gender, patient age, patient pain
When the data will become available and for how long
After publishing the article
To whom data/document is available
Based on the University's discretion
Under which criteria data/document could be used
According to the conditions that the University determines
From where data/document is obtainable
Yasouj University of Medical Sciences, Research Deputy
What processes are involved for a request to access data/document