Evaluating the efficacy of low level laser therapy in decreasing the injection pain and post treatment pain in primary teeth
Design
Randomized clinical trial, split mouth, with crossover groups, triple blinded, over 30 patients, randomization achieved by SNOSE method.
Settings and conduct
In children within age of 6 to 9 year old visiting pediatric section of shahid beheshti dental school, requiring pulpotomy treatment in both E teeth of the maxilla and anesthesia with infiltration technique, in first session, a saline cotton is used to the site of injection and then low level laser is radiated to the site and the injection is performed. In the next session, a cotton smeared with topical anesthesia gel is used on the site of injection, and then the laser device is pointed to the site while the power is off, and then the injection is performed. At the end of each injection, the severity of pain is assessed by the Visual Analogue Scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Need of pulpotomy treatment for both upper jaw E teeth requiring infiltration injection
No history of bad dental treatment
Children within age of 6 to 9 year old
Exclusion criteria:
Systemic disease
Allergy to anesthesia drug
Inflammation in the site of injection
No consent of parents to participate in the study
Intervention groups
First Intervention group: radiation of low level laser therapy on tooth E of the maxilla on one side of a patient
Second Intervention group: use of topical anesthesia gel on tooth E of the maxilla on the other side of the same patient
Main outcome variables
Severity of pain during injection
Severity of pain after the removal of anesthesia after 1 hour and 24 hours of the treatment
General information
Reason for update
Acronym
LLLT
IRCT registration information
IRCT registration number:IRCT20210914052474N1
Registration date:2021-11-04, 1400/08/13
Registration timing:prospective
Last update:2021-11-04, 1400/08/13
Update count:0
Registration date
2021-11-04, 1400/08/13
Registrant information
Name
Fatemeh Shekarchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2217 5350
Email address
f.shekarchi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of low level laser therapy in decreasing the injection pain and post treatment pain in primary teeth
Public title
Evaluating the efficacy of low level laser therapy in decreasing the injection pain and post treatment pain in primary teeth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Need of pulpotomy treatment in bilateral first primary molar teeth of upper jaw requiring infiltration anesthesia
No record of bad dental treatment in the past
Children within age of 6 to 9 year old
Exclusion criteria:
Systemic disease
Allergy to local anesthesia drug
Inflammation in the site of injection
No consent of the parents to participate in the study
Age
From 6 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patient is blinded by putting shield glasses on his/her eyes and thus he/she is unaware about the activation of the laser device.
Result assessor is unaware about which method is used in the session and will only enters the pain score and so on he/she is blinded.
The data is given to the analyzer by certain codes and he analyzes only the codes without knowing about their nature.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research institute of dental sciences- Shahid Beheshti university of medical sciences
Street address
No. 4, Moqadam close, South Ramin St, East Ferdows Blvd
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 recorded data can be shared based on the studied indicators after identifying the sample individuals. These data include the numbers and scores reported from the Wong Baker FACES pain rating scale, and numbers recorded from the finger pulse oximeter at specified times, as well as results of statistical analysis of these data.
When the data will become available and for how long
e.g., starting 6 months after publication
To whom data/document is available
Researchers working in academic and scientific institutes can apply for access to the data.
Under which criteria data/document could be used
Performing statistical analyzes to compare data with other studies in this field is one of the conditions for access to data, so the analysis must be appropriate to the type of data received from the applicant.
From where data/document is obtainable
Applicants can obtain access to the data by submitting a request to the following email addresses in due time:
soroush.amn@yahoo.com
fshekarchi92@gmail.com
What processes are involved for a request to access data/document
After submitting the request by email, the applicant will be able to access the information within one week after submitting the request, if he/she has the requisite conditions.