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
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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RECRUITING
NA
63 participants
INTERVENTIONAL
2024-04-16
2024-12-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
low-level laser
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.
microcurrent stimulation
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.
placebo
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
microcurrent stimulation
children will be allocated to the device then the gag reflex will be re-evaluated
placebo
children will be allocated to a deactivated meridian pen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 sensitive to alginate
6 Years
9 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Marwa Baraka
Lecturer, Pediatric dentistry department
Principal Investigators
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sawsan hafez, PHD
Role: STUDY_CHAIR
Alexandria University
Locations
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Alexandria University
Alexandria, , Egypt
Countries
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Central Contacts
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marwa baraka, PHD
Role: CONTACT
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.
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.
Other Identifiers
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0800_11/2023
Identifier Type: -
Identifier Source: org_study_id
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