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

NCT06422286 | Recruiting DMC

• 1 other identifier: 0800_11/2023
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gagging

Keywords

gag reflex; dental anxiety; low-level laser

Outcome Measures

Primary Outcomes (1)

• gagging prevetive index

  the difference in gagging preventive index before and after the intervention

  immediately after the intervention

Secondary Outcomes (1)

• anxiety

  immediately after the intervention

Study Arms (3)

children allocated to low-level laser

EXPERIMENTAL

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 allocated to microcurrent electrical stimulation

EXPERIMENTAL

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

placebo control group

PLACEBO COMPARATOR

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

Device: placebo

Interventions

low-level laser DEVICE

children will be allocated to the device then the gag reflex will be re-evaluated

children allocated to low-level laser

microcurrent stimulation BIOLOGICAL

children will be allocated to the device then the gag reflex will be re-evaluated

Also known as: meridian pen

children allocated to microcurrent electrical stimulation

placebo DEVICE

children will be allocated to a deactivated meridian pen

placebo control group

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, Egypt

RECRUITING

Related Publications (2)

• Baraka M, Zeitoun SI, Salah S, Hafez S. Comparative efficacy of laser and electroacupuncture on anxiety management and salivary alpha-amylase levels in pediatric dental patients with excessive gag reflexes: a randomized clinical trial. BMC Oral Health. 2025 Jul 26;25(1):1254. doi: 10.1186/s12903-025-06630-x.

  PMID: 40713587 DERIVED

• Salah S, Hafez S, Baraka M. Effect of Low-Level Laser Acupuncture and Microcurrent Electrical Stimulation on Gag Reflex in Children During Dental Impression: A Randomized Controlled Clinical Trial. Int J Paediatr Dent. 2025 Jul;35(4):848-856. doi: 10.1111/ipd.13296. Epub 2025 Jan 23.

  PMID: 39846139 DERIVED

MeSH Terms

Conditions

Gagging

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• sawsan hafez, PHD

  Alexandria University

  STUDY CHAIR

Central Study Contacts

sara salim, master

CONTACT

01026643894; sarasalahsaleem@gmail.com

marwa baraka, PHD

CONTACT

01000804757

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Pediatric dentistry department

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 20, 2024
• Study Start: April 16, 2024
• Primary Completion: August 16, 2024
• Study Completion: December 16, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Locations

EG (1)