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Clinical Trials/NCT04243811
NCT04243811
Withdrawn
Not Applicable

Efficacy of Low Level Laser Therapy in the Management of Injection Pain During Supraperiosteal Anesthesia in Children: A Randomize Clinical Trial

Okan University1 site in 1 countryNovember 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Anesthesia
Sponsor
Okan University
Locations
1
Primary Endpoint
Face, Legg, Cry, Consolability Scale (FLACC)
Status
Withdrawn
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 15, 2020
End Date
August 15, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Okan University
Responsible Party
Principal Investigator
Principal Investigator

Sinem yildirim

Assist. Prof. Dr.

Okan University

Eligibility 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

Outcomes

Primary Outcomes

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.

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").

Study Sites (1)

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