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

NCT ID: NCT06422286

Last Updated: 2024-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-16

Study Completion Date

2024-12-16

Brief Summary

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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

Detailed Description

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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.

Conditions

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Gagging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

low-level laser

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

microcurrent stimulation

Intervention Type BIOLOGICAL

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

placebo control group

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DEVICE

children will be allocated to a deactivated meridian pen

Interventions

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low-level laser

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

Intervention Type DEVICE

microcurrent stimulation

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

Intervention Type BIOLOGICAL

placebo

children will be allocated to a deactivated meridian pen

Intervention Type DEVICE

Other Intervention Names

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meridian pen

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Baraka

Lecturer, Pediatric dentistry department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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sawsan hafez, PHD

Role: STUDY_CHAIR

Alexandria University

Locations

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Alexandria University

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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sara salim, master

Role: CONTACT

01026643894

marwa baraka, PHD

Role: CONTACT

01000804757

References

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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.

Reference Type DERIVED
PMID: 40713587 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39846139 (View on PubMed)

Other Identifiers

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0800_11/2023

Identifier Type: -

Identifier Source: org_study_id

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