Laser Versus Physiotherapy in Management of Bruxism in Children: RCS

NCT ID: NCT06131879

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-22

Study Completion Date

2023-10-19

Brief Summary

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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

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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

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Bruxism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized double arm controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Investigator and outcomes assessor were blinded to groups

Study Groups

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Laser acupuncture

Laser acupuncture biostimulation for temporalis and masseter muscles

Group Type EXPERIMENTAL

Laser acupuncture

Intervention Type DEVICE

Biostimulation of temporalis and masseter muscles

Modified physical therapy

Muscle relaxation and biofeedback for temporalis and masseter muscles

Group Type EXPERIMENTAL

Modified physical therapy

Intervention Type BEHAVIORAL

Progressive muscle relaxation of temporalis and masseter muscles

Interventions

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Laser acupuncture

Biostimulation of temporalis and masseter muscles

Intervention Type DEVICE

Modified physical therapy

Progressive muscle relaxation of temporalis and masseter muscles

Intervention Type BEHAVIORAL

Other Intervention Names

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Doctor smile low level laser device Relaxation and biofeedback of muscles

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Research Centre, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Farouk Rashed

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed F Rashed, Researcher

Role: PRINCIPAL_INVESTIGATOR

National Research Centre, Egypt

Locations

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National Research Centre

Dokki, Giza Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 40045349 (View on PubMed)

Other Identifiers

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4-4-3

Identifier Type: -

Identifier Source: org_study_id

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