determining the effect of 808 nm low level laser on reversing the effect of inferior alveolar nerve block in 6-9 years old children
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, sealed envelopes were used for randomization.
Settings and conduct
34 children aged 6-9 years with decayed teeth, who are indicated for pulpotomy on both sides of the mandible and are systemically healthy, with Frankel cooperation level 3 and 4 are selected as samples. Inferior alveolar nerve block is applied to them and after performing the pulpotomy treatment and after 30 minutes of applying the laser block with a wavelength of 808 nm, a point in the anesthesia injection area is irradiated. The return of the anesthetic effect was measured by touching the area and by the child's statements, and its time was recorded. On the opposite side, the laser device is placed in the area without radiation, and as a control group, it is compared with the other side in terms of the return time of the anesthesia effect and the possibility of trauma caused by biting after 24 hours. Sealed envelopes were used to determine the order of the intervention.
Participants/Inclusion and exclusion criteria
• Children with scores of 3 and 4 based on Frankel's behavioral rating scale.
• Children aged 6 to 9 have the ability to understand and respond to soft tissue sensations.
• Patients who need pulpotomy treatment of left and right mandibular molars under inferior alveolar nerve anesthesia.
Intervention groups
experimental group: 808 nm laser
control group: off mod laser
Main outcome variables
reversal of anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210914052474N2
Registration date:2023-01-04, 1401/10/14
Registration timing:prospective
Last update:2023-01-04, 1401/10/14
Update count:0
Registration date
2023-01-04, 1401/10/14
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
2023-02-20, 1401/12/01
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of 808 nm low level laser on reversing the effect of inferior alveolar nerve block in 6-9 years old children
Public title
the effect low level laser on reversing the effect of inferior alveolar nerve block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 6-9 years old without systemic disease
Children with Frankel level 3 and 4
Patients who need pulpotomy of left and right mandibular primary molars under inferior alveolar nerve block.
Exclusion criteria:
history of sensitivity to anesthetics and sulfate
errors in the injection of anesthesia during 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:
34
More than 1 sample in each individual
Number of samples in each individual:
2
mandibular primary molars
Randomization (investigator's opinion)
Randomized
Randomization description
The study was conducted in a split-mouth manner, and sealed envelopes were used for randomization. In this way, envelopes are first randomly selected to determine the side under laser radiation. Then envelopes are selected to determine the type of intervention (or control) in the first session.
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
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
45 minutes after injection and then every 10 minutes
Method of measurement
touching by a sharp object
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: low level laser konftec 808 nm 6.3 J, 23s on every point will be used on 12 point (6 point intra-oral and 6 point extra-oral) 45 minutes after block injection.
Category
Treatment - Devices
2
Description
Control group: off mod laser will be located on 12 points like intervention group
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 date can be shared based on the studied indicators after identifying the samples individuals. these data include the numbers and scores reported from sensitivity to touch and trauma due to biting.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
researchers working in academic and scientific institutes can apply for access to data.
Under which criteria data/document could be used
performing statistical analysis to compare data with other studies 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
The applicant can apply for access to the data via email zahra_kia_ss@yahoo.com.
What processes are involved for a request to access data/document
after submitting the request by e-mail, the applicant will be able to access the information within one week after submitting the request, if has the request conditions.