Clincosm LogoSign in Get a demo

Laser Versus Physiotherapy in Management of Bruxism in Children: RCS

Sponsor
National Research Centre, Egypt (Other)
Overall Status
Completed
CT.gov ID
NCT06131879
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
1.9
Actual Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Laser acupuncture
  • Behavioral: Modified physical therapy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized double arm controlled studyRandomized double arm controlled study
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Investigator and outcomes assessor were blinded to groups
Primary Purpose:
Treatment
Official Title:
Evaluation of Laser Acupuncture Versus Modified Physical Therapy Intervention in Management of Bruxism in Children, Study Protocol for a Randomized Controlled Study
Actual Study Start Date :
Aug 22, 2023
Actual Primary Completion Date :
Sep 15, 2023
Actual Study Completion Date :
Oct 19, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tempro-mandibular joint pain [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 Outcome Measures

    1. Activity of temporalis and masseter muscles [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Research Centre Dokki Giza Egypt 12622

    Sponsors and Collaborators

    • National Research Centre, Egypt

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohamed Farouk Rashed, Researcher, National Research Centre, Egypt
    ClinicalTrials.gov Identifier:
    NCT06131879
    Other Study ID Numbers:
    • 4-4-3
    First Posted:
    Nov 14, 2023
    Last Update Posted:
    Nov 14, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Mohamed Farouk Rashed, Researcher, National Research Centre, Egypt
    bruxism
    laser
    children
    Physiotherapy
    Additional relevant MeSH terms:
    Bruxism

    Study Results

    No Results Posted as of Nov 14, 2023