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Laser Versus Physiotherapy in Management of Bruxism in Children: RCS

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06131879
Acronym
RCS
Enrollment
16
Registered
2023-11-14
Start date
2023-08-22
Completion date
2023-10-19
Last updated
2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruxism

Keywords

bruxism, laser, children, Physiotherapy

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

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.

Interventions

DEVICELaser acupuncture

Biostimulation of temporalis and masseter muscles

BEHAVIORALModified physical therapy

Progressive muscle relaxation of temporalis and masseter muscles

Sponsors

National Research Centre, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Investigator and outcomes assessor were blinded to groups

Intervention model description

Randomized double arm controlled study

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Tempro-mandibular joint pain2 monthsTenderness 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

MeasureTime frameDescription
Activity of temporalis and masseter muscles2 monthsActivity 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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026