Protocol summary
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Study aim
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Determination of laser application in the removal of soft tissue local anesthesia in children
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Design
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split-mouth ( each patient receives two treatments in each mandibular quadrant ) double-blind randomized clinical trial
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Settings and conduct
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This study will be carried out in children ages 4 to 8 years old referred to the pediatric dentistry department of Tehran University of Medical Sciences.
After the inclusion and exclusion criteria, patients will be randomly divided into two groups of treated with laser and without laser in two treatment sessions with an interval of 7 to 10 days (split- mouth).
Patients' sensation of soft tissue will be evaluated and recorded every 15 minutes by palpation.The patient will also be evaluated for soft tissue trauma.
clinical care, the outcome evaluator, researcher, patient and analyzer are blind at this study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
4 - 8- year-old children who are able to understand and respond to soft tissue sensation
Requiring treatment by injection under anesthetic infiltration of mandibular primary first molar
Exclusion criteria:
children with systemic conditions that prevent dental treatment under local anesthesia
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Intervention groups
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The intervention group will be exposed to diode laser radiation and in the control group, the laser when it's off is symbolically illuminated with the same distance and the same duration.
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Main outcome variables
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The reversal time for normal sensation of soft tissue and the incidence of soft-tissue trauma in the two intervention and control groups will be evaluated and compared
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180804040693N1
Registration date:
2018-08-24, 1397/06/02
Registration timing:
prospective
Last update:
2019-01-08, 1397/10/18
Update count:
1
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Registration date
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2018-08-24, 1397/06/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-09-23, 1397/07/01
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Expected recruitment end date
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2019-03-11, 1397/12/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical assessment of laser application (Photobiomodulation) for reversal of soft-tissue local anesthesia in children
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Public title
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The effect of laser on soft tissue anesthesia
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
A child aged 4 to 8 years who is able to understand and respond to soft tissue sensation
Complete the informed consent form by the parent or legal guardian of the patient
Children who are ranked 3 or 4 on Frankl Rating
Requiring treatment by injection under anesthetic infiltration of mandibular primary first molar
Exclusion criteria:
History of allergy to the substance of numbness and sulfite
Receiving any pain medication at least 24 hours before treatment
Any systemic conditions that prevent dental treatment under local anesthesia
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Age
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From 4 years old to 8 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
34
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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After reviewing the inclusion and exclusion criteria, each patient randomly using simple randomization and individual (open envelope sealed) divided into two groups of treated with laser and without laser in two treatment sessions with an interval of 7 to 10 days (split- mouth).
There are 9 envelopes from each of the four modes (right with laser radiation, right without laser radiation, left with laser radiation, left without laser radiation). We ask a patient to choose an envelope from 36 envelopes and the envelope will be opened by the person responsible for the laser radiation at the same time.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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For blind clinical care and the outcome evaluator and researcher, a separate person is responsible for laser radiation. So these people are blind at all stages of the laser radiation protocol.
For blind the patient, at a meeting without laser treatment, the extinguishing laser appears symbolically with the same distance and the same duration of exposure.
For blind analyzer, first analysis is done and then grouped into groups.
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Placebo
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Used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-07-21, 1397/04/30
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Ethics committee reference number
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IR.TUMS.DENTISTRY.REC.1397.057
Health conditions studied
1
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Description of health condition studied
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The effect of laser in reversing local anesthesia
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ICD-10 code
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Y48.3
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ICD-10 code description
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Local anaesthetics (Adverse effect in therapeutic use)
Primary outcomes
1
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Description
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Time of soft tissue local anesthesia
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Timepoint
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Assessment of sensation of soft tissue every 15 minutes
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Method of measurement
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Palpation with explorer in trained child
Secondary outcomes
1
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Description
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Trauma to soft tissue
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Timepoint
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At the end of the treatment and 24 hours later
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Method of measurement
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Observation
Intervention groups
1
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Description
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Intervention group: Laser therapy with an 810 nm wavelength laser diode (Fox, ARC laser Germany) with a 0.5 cm2 cross-section handpiece with a density of 6 J / cm2, a power of 200 mw, and an irradiation time of 15 seconds per continuous wave in soft tissue at the injection side (Infiltration point and anesthetized points on the lower lip)
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Category
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Treatment - Other
2
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Description
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Control group: The Laser when it's off is symbolically illuminated with the same distance and the same duration
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Laser Research Center of Dentistry, Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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information about the main outcome
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When the data will become available and for how long
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Starting the access period from 1399
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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further research
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From where data/document is obtainable
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Email to z-hosseini@razi.tums.ac.ir
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What processes are involved for a request to access data/document
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Explain the use of documentation that will be
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Comments
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