## Protocol Section
### Identification Module
**NCT ID:** NCT06422286

**Brief Title:** Efficacy of Low-level Laser Acupuncture and Microcurrent Electrical Stimulation on Gag Reflex on Children

**Official Title:** Efficacy of Low-level Laser Acupuncture and Microcurrent Electrical Stimulation on Gag Reflex on Children During Taking Dental Impression

#### Organization Study ID Info
**ID:** 0800_11/2023
#### Organization
**Class:** OTHER
**Full Name:** Alexandria University
### Status Module
#### Completion Date
**Date:** 2024-12-16

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-18

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-08-16

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-16

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-24
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Alexandria University

#### Responsible Party

**Investigator Affiliation:** Alexandria University

**Investigator Full Name:** Marwa Baraka

**Investigator Title:** Lecturer, Pediatric dentistry department

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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

**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 Module

**Conditions:**

- Gagging

**Keywords:**

- gag reflex

- dental anxiety

- low-level laser

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 63

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Device: low-level laser

**Label:** children allocated to low-level laser

**Type:** EXPERIMENTAL

#### Arm Group 2

**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.

**Intervention Names:**

- Biological: microcurrent stimulation

**Label:** children allocated to microcurrent electrical stimulation

**Type:** EXPERIMENTAL

#### Arm Group 3

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

**Intervention Names:**

- Device: placebo

**Label:** placebo control group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- children allocated to low-level laser

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

**Name:** low-level laser

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- children allocated to microcurrent electrical stimulation

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

**Name:** microcurrent stimulation

**Other Names:**

- meridian pen

**Type:** BIOLOGICAL

#### Intervention 3

**Arm Group Labels:**

- placebo control group

**Description:** children will be allocated to a deactivated meridian pen

**Name:** placebo

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** the difference in gagging preventive index before and after the intervention

**Measure:** gagging prevetive index

**Time Frame:** immediately after the intervention

#### Secondary Outcomes

**Description:** dental anxiety will be measured before and after the intervention using pulse oximeter

**Measure:** anxiety

**Time Frame:** immediately after the intervention

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 9 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sarasalahsaleem@gmail.com

**Name:** sara salim, master

**Phone:** 01026643894

**Role:** CONTACT

**Contact 2:**

**Name:** marwa baraka, PHD

**Phone:** 01000804757

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Alexandria

**Country:** Egypt

**Facility:** Alexandria University

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Alexandria University

**Name:** sawsan hafez, PHD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012817

- Term: Signs and Symptoms, Digestive

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M8802

- Name: Gagging

- Relevance: HIGH

- As Found: Gag Reflex

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005683

- Term: Gagging

### Misc Info Module

- Version Holder: 2024-05-31
