GaggingNCT06422286
Efficacy of Low-level Laser Acupuncture and Microcurrent Electrical Stimulation on Gag Reflex on Children
A study testing low-level laser and microcurrent stimulation in people with Gagging, run by Alexandria University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Gagging
- What is being tested?
- low-level laser and microcurrent stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Apr 2024to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- children taking anti-emetic drugs
- children sensitive to alginate
Trial locations and contacts
1 site in 1 country.
marwa baraka, PHD contact
About this study
Official title: Efficacy of Low-level Laser Acupuncture and Microcurrent Electrical Stimulation on Gag Reflex on Children During Taking Dental Impression
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
Read the detailed 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.
- Conditions
- Gagging
- Being tested
- low-level laser, microcurrent stimulation, placebo
- Keywords
- gag reflex, dental anxiety, low-level laser
- Medical subject headings
- Gagging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-level laserDevice
children will be allocated to the device then the gag reflex will be re-evaluated
microcurrent stimulationBiological
Also called meridian pen
children will be allocated to the device then the gag reflex will be re-evaluated
placeboDevice
children will be allocated to a deactivated meridian pen
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
gagging prevetive index
the difference in gagging preventive index before and after the intervention
Measured: immediately after the intervention
Secondary outcomes (1)
anxiety
dental anxiety will be measured before and after the intervention using pulse oximeter
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start16 Apr 2024
- Primary completion16 Aug 2024 (estimated)
- Study completion16 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GaggingStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Baraka, Alexandria University
- Investigators
- sawsan hafez, PHD, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422286
- Sponsor's protocol ID
- 0800_11/2023
- Status last verified
- May 2024
- First submitted
- 24 Apr 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40713587Salah 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.
PubMed 39846139
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low-level Laser Acupuncture and Microcurrent Electrical Stimulation on Gag Reflex on Children During Taking Dental Impression
- ClinicalTrials.gov ID
- NCT06422286
- Acronym / sponsor ID
- 0800_11/2023
- Conditions
- Gagging
- Keywords
- gag reflex, dental anxiety, low-level laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 16 Aug 2024 (estimated)
- Study completion
- 16 Dec 2024 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| children allocated to low-level laser | Experimental | Device: low-level laserThe 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. |
| children allocated to microcurrent electrical stimulation | Experimental | Biological: microcurrent stimulationA 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. |
| placebo control group | Placebo comparator | Device: placeboA meridian acupuncture pen will be deactivated by the operator. Then an alginate impression is going to be taken. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- children taking anti-emetic drugs
- children sensitive to alginate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-level laserchildren will be allocated to the device then the gag reflex will be re-evaluated | Device | children allocated to low-level laser |
| microcurrent stimulationAlso: meridian penchildren will be allocated to the device then the gag reflex will be re-evaluated | Biological | children allocated to microcurrent electrical stimulation |
| placebochildren will be allocated to a deactivated meridian pen | Device | placebo control group |
Primary outcome
gagging prevetive index
Time frame: immediately after the intervention
the difference in gagging preventive index before and after the intervention
1 secondary outcome
anxiety
Time frame: immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Derived from this study: PubMed 40713587Baraka 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.
- Derived from this study: PubMed 39846139Salah 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
marwa baraka, PHD contact
sawsan hafez, PHD study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-level laser and microcurrent stimulation in people with Gagging, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sara salim, master (01026643894, sarasalahsaleem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gagging prevetive index (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06422286, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.