Laser Versus Physiotherapy in Management of Bruxism in Children: RCS

Bruxism Clinical Trial

— RCS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06131879
• Other study ID #: 4-4-3
• Status: Completed
• Phase: N/A
• Start date: August 22, 2023
• Est. completion date: October 19, 2023

Study information

• Verified date: November 2023
• Source: National Research Centre, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 19, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Bruxism

Intervention

Device:
• Laser acupuncture
Biostimulation of temporalis and masseter muscles

Behavioral:
• Modified physical therapy
Progressive muscle relaxation of temporalis and masseter muscles

Locations

Country	Name	City	State
Egypt	National Research Centre	Dokki	Giza

Sponsors (1)

Lead Sponsor	Collaborator
National Research Centre, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Activity of temporalis and masseter muscles	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)	2 months