Efficacy of Low Level Laser Therapy on İnjection Pain

NCT04243811 | Withdrawn

• 1 other identifier: 2018/47
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Pediatric Anesthesia; Low Level Laser Theraphy

Keywords

pediatric patient; injection pain; lllt

Outcome Measures

Primary Outcomes (2)

• Wong-Baker Faces Pain Rating Scale (PRS)

  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").

  1 year

• Face, Legg, Cry, Consolability Scale (FLACC)

  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.

  1 year

Study Arms (2)

laser group

EXPERIMENTAL

local anesthesia applyed with 940 nm diode laser

Device: Diode Laser

conventional group

ACTIVE COMPARATOR

local anesthesia applyed with topical anesthesia

Other: topical anesthesia

Interventions

Diode Laser DEVICE

LLLT with dental needle for local anesthesia during dental treatment

laser group

topical anesthesia OTHER

topical anesthesia with dental needle for local anesthesia during dental treatment

conventional group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• years old patients who are compatible with routine dental treatments in the pediatric clinic

You may not qualify if:

• 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

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Okan University Faculty of Dentistry

Istanbul, 34959, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Lasers, Semiconductor; Anesthesia

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 28, 2020
• Study Start: November 15, 2020
• Primary Completion: May 15, 2021
• Study Completion: August 15, 2021
• Last Updated: May 6, 2020

Record last verified: 2020-05

Locations

TU (1)