Evaluation of vibratory stimulation and cooling and topical anesthesia efficacy on pain during needle insertion and local anesthesia injection in anterior maxilla: a randomized clinical trial
Evaluation of vibratory stimulation and cooling and topical anesthesia gel efficacy on pain during needle insertion and local anesthesia injection in anterior maxilla
Design
Parallel group randomised trial, single blind, phase 2-3, 200 patient. Randomisation is done with eight blocks.
Settings and conduct
The research site is in the endodontics department of the School of Dentistry of Isfahan University of Medical Sciences. In this study, the effect of vibration, cold and anesthesia gel before injection in the anterior part of the maxilla, on the amount of pain during needle insertion and injection of anesthetic is investigated. No intervention is performed before injection of anesthesia in the control group. This study is performed in a single-blind manner. One person performs all the injections, knowing how to assign individuals to the four intervention groups.The other person will not know what group everyone is in and will receive a pain score from the patients. The person for whom blinding is performed in this study is responsible for evaluating patients' pain after the intervention.
Participants/Inclusion and exclusion criteria
Patient in the ASA I classification range in age between 18 and 60 years. Teeth that require root canal treatment in the anterior maxilla with asymptomatic irreversible pulpitis, normal periapical without periodontal disease.
Intervention groups
Before injection of anesthesia ,In first group, a cold spray-soaked ear cleaner is placed for one minute. In second group, a one-minute vibrating device is placed.In the third group, topical gel is placed for one minute. In the fourth group (control group) before injection no intervention is used.
Main outcome variables
If vibration or cold are as effective as topical gel in reducing pain when the anesthetic is injected, vibration or cold can be used before injection.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191114045442N2
Registration date:2021-06-19, 1400/03/29
Registration timing:prospective
Last update:2021-06-19, 1400/03/29
Update count:0
Registration date
2021-06-19, 1400/03/29
Registrant information
Name
Neda Shekarchizade esfahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 5052
Email address
neda_shekarchizade@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-09-06, 1400/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of vibratory stimulation and cooling and topical anesthesia efficacy on pain during needle insertion and local anesthesia injection in anterior maxilla: a randomized clinical trial
Public title
Evaluation of vibratory stimulation efficacy on pain during needle insertion and local anesthesia injection in anterior maxilla
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
(ASA I) American Society of Anesthesiologists I
Teeth with anterior maxillary root canal treatment with asymptomatic irreversible pulpitis, and normal periapical
No periodontal disease
Teeth adjacent to the target tooth should not have any infection or swelling
Have not taken medications that change the perception of pain (such as painkillers, opioids, antidepressants, anti-anxiety drugs, alcohol) in the last 2 weeks
No addiction
Do not have pain or dental infection
Exclusion criteria:
Patients who do not want to continue cooperating during the tests
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is based on block randomization using eight blocks. 25 blocks of eight quadrants will be selected randomly adopting random number table method. Patients under study will be assigned to one of two groups of intervention and control groups based on the order of blocks selection.
Blinding (investigator's opinion)
Single blinded
Blinding description
One person will do all the injections, which will show how people are assigned to the four intervention groups, and the other person will not know what group everyone is in, and will receive pain scores from patients.The person for whom blinding is performed in this study is responsible for evaluating patients' pain after the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran.
City
isfahan
Province
Isfehan
Postal code
81744-73461
Approval date
2021-03-17, 1399/12/27
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.833
Health conditions studied
1
Description of health condition studied
Asymptomatic irreversible pulpitis, normal periapical
ICD-10 code
pulpitis
ICD-10 code description
K04.0
Primary outcomes
1
Description
Pain
Timepoint
Pain when inserting a needle and pain during injecting of anesthtesia solution in the anterior region of the maxilla
Method of measurement
Heft-Parker visual analog scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:Before injection, a cold spray-soaked ear cleaner is placed in the buccal vestibule area for one minute. Intervention group 2: Before injection, a vibrating device is placed in the area of the buccal vestibule for one minute. Intervention group 3: Before injection, a topical gel is placed in the buccal vestibule area for one minute.
Category
Prevention
2
Description
Control group: without any intervention (cold-spray, vibration and topical gel), local anesthetic injection is performed with infiltration technique in the buccal vestibule area of the anterior teeth.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Endodontics, Dental School, Isfahan
Full name of responsible person
Neda Shekarchizade
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5047
Email
neda_shekarchizade@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Neda Shekarchizade
Street address
Vice chancellor for research, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran.
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 2822
Email
Neda_shekarchizade@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Neda Shekarchizade
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 2822
Email
Neda_shekarchizade@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Neda Shekarchizade
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran.
City
اصفهان
Province
Isfehan
Postal code
8173638896
Phone
+98 31 3792 2822
Email
Neda_shekarchizade@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Neda Shekarchizade
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran.
City
isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 2822
Email
Neda_shekarchizade@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
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
Title and more details about the data/document
All data can be shared after unidentified individuals.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
additional supporting information/documents will be shared only for people working in academic institutions
Under which criteria data/document could be used
Any analysis of the data is allowed.
From where data/document is obtainable
Dr Neda Shekarchizade
Email: Neda_shekarchizade@yahoo.com
What processes are involved for a request to access data/document
It takes about a month for the documentation to reach the applicant.