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

Alexandria University

Status: Enrolling

Conditions: Gagging

Treatments: Biological: microcurrent stimulation; Device: low-level laser; Device: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06422286

0800_11/2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 63 estimated patients

Sex: All

Ages: 6 to 9 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 3 patient groups, including a placebo group

children allocated to low-level laser

Experimental group

Description:

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.

Treatment:

Device: low-level laser

children allocated to microcurrent electrical stimulation

Experimental group

Description:

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.

Treatment:

Biological: microcurrent stimulation

placebo control group

Placebo Comparator group

Description:

A meridian acupuncture pen will be deactivated by the operator. Then an alginate impression is going to be taken.

Treatment:

Device: placebo