Efficacy of Low-level Laser Acupuncture and Microcurrent Electrical Stimulation on Gag Reflex on Children

Efficacy of Low-level Laser Acupuncture and Microcurrent Electrical Stimulation on Gag Reflex on Children During Taking Dental Impression

the aim of the current study is to evaluate the effectiveness of the laser acupuncture in comparison to the electroacupuncure for controlling gag reflex in children

Study Overview

• Status: Recruiting
• Conditions: Gagging
• Intervention / Treatment: Device: low-level laser; Biological: microcurrent stimulation; Device: placebo

Detailed Description

the study will select children who are suffering from gag reflex that can affect their dental appointments negatively. they will be diagnosed then randomly distributed to one of the 3 groups of the study gag reflex and anxiety will be measured before and after the intervention then the results will be compared.

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: sara salim, master; Phone Number: 01026643894; Email: sarasalahsaleem@gmail.com
• Study Contact Backup: Name: marwa baraka, PHD; Phone Number: 01000804757

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• children free of any systemic disease or special health care needs
• children with score 2 or 3 according to the frankle behavioral rating scale
• a full arch maxillary alginate impression is needed
• moderate to severe gagging according to the gagging severity index
• written informed consent of the legal guardian

Exclusion Criteria:

• children taking anti-emetic drugs
• children sensitive to alginate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: children allocated to low-level laser; The laser device with wavelength 940 nm, energy 4J, and 3-4 mm away from the tissue is applied on PC6 acupoint without causing pain to the patient for 1 minute. Immediately after the laser acupuncture, an alginate impression is going to be taken.	Device: low-level laser; children will be allocated to the device then the gag reflex will be re-evaluated
Experimental: children allocated to microcurrent electrical stimulation; A meridian acupuncture pen with AA battery will be applied on PC6 for one minute. Immediately after using the meridian pen, an alginate impression is going to be taken.	Biological: microcurrent stimulation; children will be allocated to the device then the gag reflex will be re-evaluated; Other Names: meridian pen
Placebo Comparator: placebo control group; A meridian acupuncture pen will be deactivated by the operator. Then an alginate impression is going to be taken.	Device: placebo; children will be allocated to a deactivated meridian pen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gagging prevetive index	the difference in gagging preventive index before and after the intervention	immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anxiety	dental anxiety will be measured before and after the intervention using pulse oximeter	immediately after the intervention

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Chair: sawsan hafez, PHD, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Estimated): August 16, 2024
• Study Completion (Estimated): December 16, 2024

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: May 18, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 18, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: dental anxiety; low-level laser; gag reflex
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Gagging
• Other Study ID Numbers: 0800_11/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No