The study of the synergistic effects of perilocaine and lidocaine on local anesthesia
Design
A total of 60 patients referred to the Department of Endodontics of Shahid Sadoughi Dental School in Yazd, who have a mandibular molar with an irreversible symptomatic pulpitis, are diagnosed with root canal therapy and are considered as systemic predisposing conditions for injectable solutions Periclase and lidocaine do not contain epinephrine. The number of patients was determined based on similar studies.
Settings and conduct
Shahid Sadoughi Faculty of Dentistry, Yazd
Participants/Inclusion and exclusion criteria
1. Mandibular molar teeth with irreversible pulpitis
2. The teeth can be repaired.
3- Apex toothpaste (age over 18)
4. Awareness is normal and can respond to vital tests.
Intervention groups
A group whose second numbness is perlocaine.
Main outcome variables
Local anesthesia depth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190315043057N1
Registration date:2019-04-17, 1398/01/28
Registration timing:registered_while_recruiting
Last update:2019-04-17, 1398/01/28
Update count:0
Registration date
2019-04-17, 1398/01/28
Registrant information
Name
Jalil Modaresi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3625 5881
Email address
j.modaresi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-08, 1398/01/19
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of synergism of prilocaine and lidocaine in local anesthesia in patients with irreversible palpitis
Public title
Evaluation of synergism of prilocaine and lidocaine in local anesthesia in patients with irreversible palpitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mandibular molar teeth with irreversible pulpitis
The teeth can be restoreable
Tooth apex is closed (age +18)
The patient who has normal intelligence and are able to meet the critical tests
Exclusion criteria:
Patients with systemic problems that have a contraindication for lower alveolar block injections, such as those with hemorrhagic problems
A history of allergy to local anesthetics of dentistry
Use of the medication 24 hours before local anesthetic injection
Patients that have a contraindications for use of any of the drugs used in the study (epinephrine, lidocaine, perilocaine)
Disturbance in vital signs of the patient after local anesthetic injection
Tooth with severe periodontal disease
A teeth with sensitivity to percussion or has periapical pathological symptoms in radiography
The absence of a healthy tooth or a teeth with small restoration on the opposite side as a control tooth
During the study, patient dissatisfaction and announced withdrawal
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
After the first injection with lidocaine anesthesia, in the first patient, the second injection is done using the heads or tails method, One of the anesthetics of perylocaine or lidocaine is chosen as second anesthetic solution. In all odd number sample cases, this anesthetic solution (perlucaine or lidocaine) and for all cases with even number, other anesthetic solution are selected as the second anesthetic solution.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research
Street address
Bahonar Square- Shahid sadoghi medical university central park
City
Yaz
Province
Yazd
Postal code
8916978477
Approval date
2018-11-04, 1397/08/13
Ethics committee reference number
IR.SSU.REC.1397.088
Health conditions studied
1
Description of health condition studied
Irreversible Pulpits
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
depth of local anesthesia
Timepoint
10 min after injection of local anesthesia
Method of measurement
Using pulse electric tester, cold test and patient response to the VAS chart
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group whose second anesthesia is a Perilocaine solution
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid sadoghi dental university
Full name of responsible person
Seyed jalil Modaresi
Street address
Shahid Sadoghi Square- Shahid Sadoghi dental university
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
j.modaresi@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Jalil Modaresi
Street address
Bahonar Suare- Shahi dadoghi Dental University
City
Yaz
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
j.modaresi@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Seyed Jalil Modaresi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bahonar Suare- Shahi dadoghi Dental University
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3763 3733
Email
j.modaresi@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Jalil modaresi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bahonar Suare- Shahi dadoghi Dental University
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
j.modaresi@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Jalil Modaresi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bahonar Suare- Shahi dadoghi Dental University
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
j.modaresi@ssu.ac.ir
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
Undecided - It is not yet known if there will be 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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available