Protocol summary

Study aim
The Comparison of maxillary infiltration and mandibular block injection effect on the cardiovascular parameters with 2 different local anesthesia solutions, Lidocaine and prilocaine
Design
Clinical trials with Parallel, Double blind, randomized groups
Settings and conduct
112 patients referring to the dental school of Kermanshah University of Medical Sciences will be chosen. Patients are randomly divided into four groups, Groups included: 1.Block injection in mandible with 2% lidocaine solution with epinephrine 1: 80,000, 2.infiltration injection in maxilla with lidocaine 2% solution with epinephrine 1: 80,000, 3.Block injection in mandible with prilocaine solution, 4. infiltration injection in maxilla with prilocaine solution. Systolic and diastolic blood pressure and heart rate and blood oxygen saturation percentage will be evaluated, In the four stages. A dark tape will cover each anesthetic cartridge.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People aged 20-50 years, Have general health, needing restorative treatment of maxillary or mandibular molar teeth. Exclusion criteria: medical history of cardiovascular, hypertension, Diabetes, kidney diseases, gastrointestinal bleeding or ulceration, Use of medications that make disturbance in function of anesthetic substance, Patients with pathology problems at the injection site, pregnant and nursing patients
Intervention groups
Block injection in mandible with 2% lidocaine solution with epinephrine 1: 80,000, infiltration injection in maxilla with lidocaine 2% solution with epinephrine 1: 80,000, Block injection in mandible with prilocaine 3% solution, infiltration injection in maxilla with prilocaine 3% solution
Main outcome variables
Level of systolic blood pressure, Level of diastolic blood pressure, Heart rate per minute, Peripheral blood oxygen saturation percentage

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140527017880N6
Registration date: 2018-05-12, 1397/02/22
Registration timing: prospective

Last update: 2018-05-12, 1397/02/22
Update count: 0
Registration date
2018-05-12, 1397/02/22
Registrant information
Name
Roohollah Sharifi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1722 2400
Email address
r.sharifi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-20, 1397/02/30
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative evaluation of maxillary infiltration and mandibular block injection effect on the cardiovascular parameters with 2 different local anesthesia solutions, Lidocaine and prilocaine in Patients Requiring Restorative Treatment of molar Teeth
Public title
The Comparison of maxillary infiltration and mandibular block injection effect on the cardiovascular parameters with 2 different local anesthesia solutions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People aged 20-50 years Have general health needing restorative treatment of maxillary or mandibular molar teeth
Exclusion criteria:
Patients with medical history of cardiovascular, hypertension, Diabetes, kidney diseases, gastrointestinal bleeding or ulceration Use of medications that make disturbance in function of anesthetic substance Patients with pathology problems at the injection site pregnant and nursing patients
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 112
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization tools are sealed envelopes. Random unit is of individual type. Randomization is a simple way so that numbness cartridges are covered by covers and for each type of numbness we consider one of the numbers 1 and 2 and write the considered number on the cartridges covered with the covers (Each number represents a particular type of anesthetic substance). Then the patient chooses one of these cartridges. These cartridges are provided to patients who visit the Dental Clinics of Kermanshah from May 20, 2018 to June 20, 2018 for restoration of the molar teeth. Placing covers and writing numbers is done only by one of the researchers, so the injector, the evaluator and the participant, are unaware of the type of anesthesia.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both anesthetics used in the study are safe and do not pose a risk to patients. Before doing the study, written consent is taken from the patients. One of the cartridges covered with a cover that one of the numbers 1 and 2 is written on it, Is selected by the patient (Each number represents a particular type of anesthetic substance). Placing covers and writing numbers is done only by one of the researchers, so the injector, the evaluator and the participant, are unaware of the type of anesthesia.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Ethics Committee of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
67146673159
Approval date
2017-10-25, 1396/08/03
Ethics committee reference number
ir.kums.rec.1396.389

Health conditions studied

1

Description of health condition studied
Local anaesthetics
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics

Primary outcomes

1

Description
Level of systolic blood pressure
Timepoint
10 minutes before injection, immediately after injection, 10 minutes after injection, 20 minutes after injection
Method of measurement
automatic brachial pressure gauge device

2

Description
Level of diastolic blood pressure
Timepoint
10 minutes before injection, immediately after injection, 10 minutes after injection, 20 minutes after injection
Method of measurement
automatic brachial pressure gauge device

3

Description
Heart rate per minute
Timepoint
10 minutes before injection, immediately after injection, 10 minutes after injection, 20 minutes after injection
Method of measurement
Finger pulse oximeter

4

Description
Peripheral blood oxygen saturation percentage
Timepoint
10 minutes before injection, immediately after injection, 10 minutes after injection, 20 minutes after injection
Method of measurement
Finger pulse oximeter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Block injection in mandible with 1/8 milliliter of lidocaine 2% solution with epinephrine 1: 80,000 (Darou Pakhsh/iran)
Category
Treatment - Other

2

Description
Intervention group: infiltration injection in maxilla with 1/8 milliliter of lidocaine 2% solution with epinephrine 1: 80,000 (Darou Pakhsh/iran)
Category
Treatment - Other

3

Description
Intervention group: Block injection in mandible with 1/8 milliliter of prilocaine Hcl 3% solution with felypressin 0.03 IU (Darou Pakhsh/iran)
Category
Treatment - Other

4

Description
Intervention group: infiltration injection in maxilla with 1/8 milliliter of prilocaine Hcl 3% solution with felypressin 0.03 IU (Darou Pakhsh/iran)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Restorative, School of Dentistry, Kermanshah University of Medial Sciences.
Full name of responsible person
Dr Roohollah Sharifi
Street address
Shariati st
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3727 7030
Email
roholahsharifi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid najafi
Street address
Building No.2, Shahid Beheshti Boulverd, Vice Chancellor for Research, Kermafnshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
67146673159
Phone
+98 83 3838 4185
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Zahra lami
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Opposite of the post office, Shora st, Dr Shariati st, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 2400
Email
zahra.lami@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Roohollah Sharifi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Opposite of the post office, Shora st, Dr Shariati st, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 7151
Fax
+98 83 3722 2400
Email
roholahsharifi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Zahra lami
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Opposite of the post office, Shora st, Dr Shariati st, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 2400
Email
zahra.lami@yahoo.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
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
The comparative evaluation of maxillary infiltration and mandibular block injection effect on the cardiovascular parameters with 2 different local anesthesia solutions, Lidocaine and prilocaine in Patients Requiring Restorative Treatment of molar Teeth
When the data will become available and for how long
The start of the access period is 6 months after the results are printed
To whom data/document is available
Study data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Access to study data is allowed
From where data/document is obtainable
Dr Roohollah Sharifi, Faculty Member of Kermanshah University of Medical Sciences Mobile phone: 09122177490
What processes are involved for a request to access data/document
The data can be submitted to Dr. Rouhollah Sharifi by sending an email. r.sharifi@kums.ac.ir
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