## Protocol Section
### Identification Module
**NCT ID:** NCT06131879

**Acronym:** RCS

**Brief Title:** Laser Versus Physiotherapy in Management of Bruxism in Children: RCS

**Official Title:** Evaluation of Laser Acupuncture Versus Modified Physical Therapy Intervention in Management of Bruxism in Children, Study Protocol for a Randomized Controlled Study

#### Organization Study ID Info
**ID:** 4-4-3
#### Organization
**Class:** OTHER
**Full Name:** National Research Centre, Egypt
### Status Module
#### Completion Date
**Date:** 2023-10-19

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-14

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-09-15

**Type:** ACTUAL

#### Start Date
**Date:** 2023-08-22

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2023-11-14
**Type:** ACTUAL
**Study First Submit Date:** 2023-10-20
**Study First Submit QC Date:** 2023-11-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** National Research Centre, Egypt

#### Responsible Party

**Investigator Affiliation:** National Research Centre, Egypt

**Investigator Full Name:** Mohamed Farouk Rashed

**Investigator Title:** Researcher

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The goal of this randomized controlled study is to compare laser acupuncture versus modified physical therapy in controlling bruxism in children. The main questions aim to answer are:

* Laser will decrease tempro-mandibular joint pain from bruxism more than modified physical therapy?
* Laser will decrease muscles activity from bruxism more than modified physical therapy? Children took 6 sessions of either laser acupuncture or modified physical therapy Researchers compared laser acupuncture versus modified physical therapy to see if any decrease in tempro-mandibular joint pain and muscles activity from bruxism

**Detailed Description:** The children participated in the study as bruxers according to the American Association of Sleep Medicine (AASM) diagnostic criteria \[ Sixteen children will be randomly allocated to two groups of 8 individuals each: Group one: laser acupuncture, Group two: electromyography biofeedback training.

Pain will be measured by Visual Analogue scale; VAS (primary outcome)and muscle activity will be measured by Electromyography (Secondary outcome) of temporalis and masseter muscles. Measurements will be taken preoperatively and after 8 weeks.

### Conditions Module

**Conditions:**

- Bruxism

**Keywords:**

- bruxism

- laser

- children

- Physiotherapy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized double arm controlled study

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** Investigator and outcomes assessor were blinded to groups

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 16

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Laser acupuncture biostimulation for temporalis and masseter muscles

**Intervention Names:**

- Device: Laser acupuncture

**Label:** Laser acupuncture

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Muscle relaxation and biofeedback for temporalis and masseter muscles

**Intervention Names:**

- Behavioral: Modified physical therapy

**Label:** Modified physical therapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Laser acupuncture

**Description:** Biostimulation of temporalis and masseter muscles

**Name:** Laser acupuncture

**Other Names:**

- Doctor smile low level laser device

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Modified physical therapy

**Description:** Progressive muscle relaxation of temporalis and masseter muscles

**Name:** Modified physical therapy

**Other Names:**

- Relaxation and biofeedback of muscles

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Tenderness and pain of temporalis and masseter muscles by visual analogue scale (VAS) of pain before and after intervention either no pain, mild pain, moderate or severe pain. Better outcome means no or mild pain

**Measure:** Tempro-mandibular joint pain

**Time Frame:** 2 months

#### Secondary Outcomes

**Description:** Activity of temporalis and masseter muscles by surface electromyography (EMG) at rest and during function (Decrease in activity by small values bymicrons means better outcome and vice versa)

**Measure:** Activity of temporalis and masseter muscles

**Time Frame:** 2 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Six to twelve years children
2. Medically free
3. Normal occlusion
4. No or low caries experience
5. Clinical dental wear
6. Clenching or grinding reported by the parents

Exclusion Criteria:

1. Children with any physical or psychological disease.
2. Children received any previous treatment for bruxism.
3. Children with tempro-mandibular joint disorders

**Healthy Volunteers:** True

**Maximum Age:** 12 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Dokki

**Country:** Egypt

**Facility:** National Research Centre

**State:** Giza

**Zip:** 12622

#### Overall Officials

**Official 1:**

**Affiliation:** National Research Centre, Egypt

**Name:** Mohamed F Rashed, Researcher

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** No plan to share results

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014076

- Term: Tooth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5286

- Name: Bruxism

- Relevance: HIGH

- As Found: Bruxism

- ID: M16831

- Name: Tooth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002012

- Term: Bruxism

### Misc Info Module

- Version Holder: 2024-05-24
