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

Gagging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06422286
• Other study ID #: 0800_11/2023
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2024
• Est. completion date: December 16, 2024

Study information

• Verified date: May 2024
• Source: Alexandria University
• Contact: sara salim, master
• Phone: 01026643894
• Email: sarasalahsaleem[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: December 16, 2024
• Est. primary completion date: August 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Gagging

Intervention

Device:
• low-level laser
children will be allocated to the device then the gag reflex will be re-evaluated

Biological:
• microcurrent stimulation
children will be allocated to the device then the gag reflex will be re-evaluated

Device:
• placebo
children will be allocated to a deactivated meridian pen

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gagging prevetive index	the difference in gagging preventive index before and after the intervention	immediately after the intervention
Secondary	anxiety	dental anxiety will be measured before and after the intervention using pulse oximeter	immediately after the intervention