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Efficacy of Low Level Laser Therapy on İnjection Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243811
Recruitment Status : Withdrawn (Due to the technical problem in the laser device,it has not started.)
First Posted : January 28, 2020
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Sinem yildirim, Okan University

Brief Summary:
The purpose of this study was to compare the pain during needle insertion and injection in supraperiosteal anesthesia with either topical anesthesia (control) or LLTT (experimental).

Condition or disease Intervention/treatment Phase
Pediatric Anesthesia Low Level Laser Theraphy Device: Diode Laser Other: topical anesthesia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Low Level Laser Therapy in the Management of Injection Pain During Supraperiosteal Anesthesia in Children: A Randomize Clinical Trial
Estimated Study Start Date : November 15, 2020
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : August 15, 2021

Arm Intervention/treatment
Experimental: laser group
local anesthesia applyed with 940 nm diode laser
Device: Diode Laser
LLLT with dental needle for local anesthesia during dental treatment

Active Comparator: conventional group
local anesthesia applyed with topical anesthesia
Other: topical anesthesia
topical anesthesia with dental needle for local anesthesia during dental treatment




Primary Outcome Measures :
  1. Wong-Baker Faces Pain Rating Scale (PRS) [ Time Frame: 1 year ]
    The PRS measures the unpleasantness or affective dimension of a child's pain experience and is used in children aged 3-17 years old. The PRS consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears, and each child is asked to select the facial expression that best represents his/her experience of discomfort. Each face has a numerical value ranging from 0 (smiling face, "no hurt") to 5 (crying/screaming face, "hurts worst").

  2. Face, Legg, Cry, Consolability Scale (FLACC) [ Time Frame: 1 year ]
    The scale comprised the following parameters: (1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability. Each of the five categories is scored from 0-2, which results in a minimum total score of 0 and maximumof 10. According to this scale: 0=Relaxed and comfortable (no pain); 1-3=Mild discomfort; 4-6=Moderate pain; and 7-10=Severe discomfort or pain [Willis et al., 2003]. Behavioural parameters were recorded.



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

In need of treatment of right and left molar teeth of maxilla,

  • Does not have any systemic disorder,
  • High level of communication that can provide logical answers to the questions we ask
  • With parental consent,
  • Volunteers who want to participate in the research
  • 6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic

Exclusion Criteria:

  • No need for treatment of right and left molar teeth of maxilla,
  • Has a systemic condition
  • Low level of communication that cannot provide reasonable answers to the questions we ask
  • Without parental consent
  • Do not want to participate voluntarily in the research
  • Do not attend a check-in
  • Patients not in the 6-12 age group

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243811


Locations
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Turkey
Okan University Faculty of Dentistry
Istanbul, Turkey, 34959
Sponsors and Collaborators
Okan University
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Responsible Party: Sinem yildirim, Assist. Prof. Dr., Okan University
ClinicalTrials.gov Identifier: NCT04243811    
Other Study ID Numbers: 2018/47
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sinem yildirim, Okan University:
pediatric patient
injection pain
lllt
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs