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Completed

NCT Number: NCT06131879

Laser Versus Physiotherapy in Management of Bruxism in Children: RCS

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

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Key information

Conditions

Bruxism Behavior Habits Stomatognathic Diseases Tooth Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Research Centre

Dokki, Giza Governorate, 12622, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Laser acupuncture

Device

Biostimulation of temporalis and masseter muscles

Other names: Doctor smile low level laser device

Modified physical therapy

Behavioral

Progressive muscle relaxation of temporalis and masseter muscles

Other names: Relaxation and biofeedback of muscles

Primary outcomes

  1. Tempro-mandibular joint pain

    Time frame: 2 months

    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

Secondary outcomes

  1. Activity of temporalis and masseter muscles

    Time frame: 2 months

    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)

Sponsors and collaborators

Lead sponsor

National Research Centre, Egypt

Other

Registry information

Official study title

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

Acronym: RCS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2023
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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