Comparison of low-power diode lasers (810 nm), gum massage (pressure), benzocaine anesthesia gel on pain during injection infiltration
Design
sham controlled clinical trial with a parallel group design؛ double blind
Settings and conduct
study will perform in endodontic department of Islamic Azad University of Tehran. 4 types of pre injection interventions will done while the volunteers and injection pain assessor are blinded.each of the four types of intervention is done for each person at intervals of one week.
Participants/Inclusion and exclusion criteria
Volunteers between 20 and 40 years with intact maxillary canine .Exclusion criteria:allergy to topical or local anesthetic agent,history of systemic disease, history of trauma in the side of injection؛ulceration or inflammation of the buccal tissue؛ history of smoking؛use of sedative or tranquilizer during the last 72 hours
Intervention groups
maxillary right canine area was prepared by laser radiation(diode laser 810nm) for12.5 second(energy density of 2 j/cm2, power 0.08 W). group2: 20% benzocaine topical anesthesia was applied for 2 min before injection. group3: pressure was applied to the anesthetized area with laser barrier in the silicone sheath for 2 min(as indicated by the observation of pale tissue).group4: control group followed by application of laser in the off mode and the placebo gel
Main outcome variables
Pain during injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141222020396N2
Registration date:2018-06-22, 1397/04/01
Registration timing:registered_while_recruiting
Last update:2018-06-22, 1397/04/01
Update count:0
Registration date
2018-06-22, 1397/04/01
Registrant information
Name
Mehdi Vatanpour
Name of organization / entity
Islamic Azad University.Dental Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
m_vatanpour@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2018-07-11, 1397/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low_level laser(810 nm),Benzocaine anesthetic gel and pressure on reducing pain during infiltration injection
Public title
The effect laser on reducing pain during injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
volunteers in the age between 20 and 40 years with intact maxillary canine,no need for dental treatment
after confirming the consent form by the volunteers and informing about the drawbacks related to the interventions and the profit from participation, included the study
Exclusion criteria:
allergy to topical or local anesthetic agent
history of systemic disease
history of truma in the injection area
ulceration or inflammation of the buccal tissue
history of smoking
The use of sedative or tranquillizers during the last 72 hours
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
16
More than 1 sample in each individual
Number of samples in each individual:
4
4 types of pre injection interventions such as: Laser, Xylocaine gel, Pressure & Placebo
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization, sequential, sealed envelop.At the first session, the patient has four sealed envelopes containing four interventions that randomly select one and the selected envelope will be deleted at next sessions(1,2,3).
Blinding (investigator's opinion)
Double blinded
Blinding description
volunteers are blind because of the complete simulation of interventions(all interventions are implemented by the low probability laser probe).and the post injection pain assessor is blind because is different with the operator.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Medical Science Branch,Islamic Azad university, Tehran
Street address
Neyestan 9th Alley, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
19585175
Approval date
2017-09-24, 1396/07/02
Ethics committee reference number
IR.IAU.DENTAL.REC.1396,22
Health conditions studied
1
Description of health condition studied
pain control
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
Immediatlely after injection
Method of measurement
Visual Analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: diode Laser 810 nm, power 0.08 W, Dose 2 J/cm2 in 12.5seconds(Dental diode laser,navidAssayesh parsian,IRAN)
Category
Prevention
2
Description
Intervention group: benzocaiene 20% gel for 2 minutes
Category
Prevention
3
Description
Intervention group: Pressure for 2 minutes while the injection area tissue is pale
Category
Prevention
4
Description
Control group: placebo which all the previous interventions will simulated for volunteers.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad university Tehran Dental branch
Full name of responsible person
Mehdi Vatanpourt
Street address
9th Neyestan, pasdaran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2276 3945
Email
m_vatanpour@dentaliau.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Habibi
Street address
Neyestan 9th Alley, Pasdaran street
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2276 3459
Email
z.habibi96@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Vatanpour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
o. 4, 10th Neyestan St. , Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2254 2740
Email
drvatanpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sohrab tour Savadkouhi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 4, 10th Neyestan St. , Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2254 2740
Email
S_savadkouhi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Habibi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 4, 10th Neyestan St. , Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2250 6546
Email
Z.habibi96@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
all the data of each volunteer can be provided after being unidentifiable.
When the data will become available and for how long
Starting 6 months after article publication
To whom data/document is available
All the volunteer can also apply to receive it.
Under which criteria data/document could be used
Any requested analysis is valid.
From where data/document is obtainable
Contact the person responsible for the study by email
What processes are involved for a request to access data/document
Information will be available within 1 month of the request