Laser Versus Physiotherapy in Management of Bruxism in Children: RCS (RCS)

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

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

Study Overview

• Status: Completed
• Conditions: Bruxism
• Intervention / Treatment: Device: Laser acupuncture; Behavioral: Modified physical therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Dokki, Giza, Egypt, 12622
      • National Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser acupuncture; Laser acupuncture biostimulation for temporalis and masseter muscles	Device: Laser acupuncture; Biostimulation of temporalis and masseter muscles; Other Names: Doctor smile low level laser device
Experimental: Modified physical therapy; Muscle relaxation and biofeedback for temporalis and masseter muscles	Behavioral: Modified physical therapy; Progressive muscle relaxation of temporalis and masseter muscles; Other Names: Relaxation and biofeedback of muscles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tempro-mandibular joint pain	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	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity of temporalis and masseter muscles	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)	2 months

Collaborators and Investigators

• Sponsor: National Research Centre, Egypt
• Investigators: Principal Investigator: Mohamed F Rashed, Researcher, National Research Centre, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2023
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): October 19, 2023

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: November 12, 2023
• First Posted (Estimated): November 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 12, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: children; Physiotherapy; laser; bruxism
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Bruxism
• Other Study ID Numbers: 4-4-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No