Low-Level Laser Therapy Versus Occlusal Splint Therapy for Bruxism in Children

NCT07865845 | Completed

• 1 other identifier: FDASU-REC IM022430
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Many children grind or clench their teeth, especially during sleep. Doctors call this bruxism. It can wear down teeth and cause jaw pain. This study compared two treatments for bruxism in children. One treatment uses a low-level laser. The other treatment is a custom mouth guard, worn at night. Thirty children, ages 6 to 12, took part. Twenty had bruxism. Researchers put these children into one of two groups by chance. One group got laser treatment. The other group wore a mouth guard. Ten more children did not have bruxism. They got no treatment. This group helped researchers compare results. Before and after treatment, researchers measured how hard each child could bite. They also asked about jaw pain, and how satisfied parents and children were. Children who received laser treatment could bite harder after treatment. The mouth guard group showed no change in biting strength. Both treatments lowered jaw pain. Most parents and children were satisfied with their treatment. These results suggest laser therapy may help children's jaw muscles work normally again.

Conditions

Bruxism; Sleep Bruxism

Keywords

Temporomandibular Muscles; Photobiomodulation; Occlusal Splint; Bite Force; Low-Level Laser Therapy; LLLT; Children; Pediatric Dentistry

Outcome Measures

Primary Outcomes (1)

• Change in Bite Force

  Maximum bilateral bite force measured using a digital bite force sensor (iBite), recorded in Newtons (N)

  Baseline and 8 weeks

Secondary Outcomes (3)

• Change in Pain Intensity

  Baseline and 8 weeks

• Parental Satisfaction with Treatment

  8 weeks (end of treatment)

• Child Satisfaction with Treatment

  8 weeks (end of treatment)

Study Arms (3)

LLLT

EXPERIMENTAL

Children with sleep bruxism received low-level laser therapy: 12 sessions of diode laser (980 nm, 0.3 W) applied to the masseter and temporalis muscles, twice weekly over 8 weeks

Device: Low-Level Laser Therapy (LLLT)

Occlusal Splint

ACTIVE COMPARATOR

Children with sleep bruxism wore a custom hard mandibular occlusal splint nightly for 8 weeks.

Device: Occlusal Splint

Control

NO INTERVENTION

Bruxism-free children assessed only at baseline, used as a normative reference for bite force. No treatment was given

Interventions

Low-Level Laser Therapy (LLLT) DEVICE

Diode laser (980 nm wavelength, 0.3 W power) applied in contact mode to six points bilaterally (three on the masseter muscle, three on the temporalis muscle), 60 seconds per point, twice weekly for 12 sessions total

LLLT

Occlusal Splint DEVICE

Custom-made hard acrylic mandibular occlusal splint, approximately 2 mm thick, covering all lower teeth, adjusted to provide even occlusal contact. Worn nightly for 8 weeks

Occlusal Splint

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• For the LLLT and occlusal splint groups:
• Age 6-12 years Clinical diagnosis of sleep bruxism based on parental report of tooth grinding and clinical signs of tooth wear Medically healthy Parental/legal guardian consent obtained
• For the control group:
• Age 6-12 years No clinical signs or parental report of bruxism Medically healthy Parental/legal guardian consent obtained

You may not qualify if:

• Current or prior use of muscle relaxants or similar medication Diagnosed temporomandibular disorder Previous or ongoing treatment for bruxism Neurological or cognitive condition affecting ability to cooperate with assessment

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Bruxism; Sleep Bruxism

Interventions

Low-Level Light Therapy; Occlusal Splints

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Full blinding of participants and the treating clinician was not feasible, as the interventions were visibly and physically distinguishable. Masking was limited to the investigator responsible for outcome assessment, who was not involved in delivering either intervention."
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Thirty children were enrolled and followed for 8 weeks in three parallel groups, with no crossover. Twenty children diagnosed with sleep bruxism were randomly allocated (simple, computer-generated randomization) to the LLLT group or the occlusal splint group (10 each). A third group of 10 bruxism-free children was recruited separately, was not randomized, and was assessed only at baseline as a normative reference for bite force.

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 8, 2026
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: June 13, 2026
• Last Updated: October 8, 2026

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning from the date of publication of the primary study results, with no planned end date, for as long as the corresponding author remains able to respond to requests
• Access Criteria: Researchers who provide a methodologically sound proposal may request access by contacting the corresponding author via email. Requests will be reviewed on a case-by-case basis to ensure appropriate use and protection of participant confidentiality.

Locations

EG (1)