Laser Versus Physiotherapy in Management of Bruxism in Children: RCS

NCT06131879 | Completed DMC

• 1 other identifier: 4-4-3
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Bruxism

Keywords

bruxism; laser; children; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Activity of temporalis and masseter muscles

  2 months

Study Arms (2)

Laser acupuncture

EXPERIMENTAL

Laser acupuncture biostimulation for temporalis and masseter muscles

Device: Laser acupuncture

Modified physical therapy

EXPERIMENTAL

Muscle relaxation and biofeedback for temporalis and masseter muscles

Behavioral: Modified physical therapy

Interventions

Laser acupuncture DEVICE

Biostimulation of temporalis and masseter muscles

Also known as: Doctor smile low level laser device

Laser acupuncture

Modified physical therapy BEHAVIORAL

Progressive muscle relaxation of temporalis and masseter muscles

Also known as: Relaxation and biofeedback of muscles

Modified physical therapy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Six to twelve years children
• Medically free
• Normal occlusion
• No or low caries experience
• Clinical dental wear
• Clenching or grinding reported by the parents

You may not qualify if:

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

Sponsors & Collaborators

• National Research Centre, Egypt: lead

Study Sites (1)

National Research Centre

Dokki, Giza Governorate, 12622, Egypt

Location

Related Publications (1)

• Rashed MF, Mohamed MA, Mohamed NER, Mansy ME. Evaluation of laser acupuncture versus physical therapy intervention in management of bruxism in children: a randomized controlled trial. BMC Oral Health. 2025 Mar 5;25(1):341. doi: 10.1186/s12903-025-05626-x.

  PMID: 40045349 DERIVED

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Study Officials

• Mohamed F Rashed, Researcher

  National Research Centre, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcomes assessor were blinded to groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: Randomized double arm controlled study

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 14, 2023
• Study Start: August 22, 2023
• Primary Completion: September 15, 2023
• Study Completion: October 19, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)