Evaluation of Low-Level Laser Therapy Versus Occlusal Splint Therapy in the Management of Bruxism in Children: A Randomized Controlled Trial
| Registry | NCT07865845 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 30 (Actual) |
| Sponsor | Ain Shams University (Other) |
| Conditions | Bruxism, Sleep Bruxism |
| Interventions | Low-Level Laser Therapy (LLLT), Occlusal Splint (Device) |
| Dates | start 2025-05-01, primary completion 2026-05-01, completion 2026-06-13, first posted 2026-10-08, last updated 2026-10-16 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Bruxism All trials for Sleep Bruxism All trials of Low-Level Laser Therapy (LLLT) All trials of Occlusal Splint
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.
This randomized controlled trial compared low-level laser therapy (LLLT) and occlusal splint therapy for the management of sleep bruxism in children aged 6-12 years. Thirty children were enrolled in three groups of 10: an LLLT group, an occlusal splint group, and a bruxism-free control group assessed only at baseline as a normative reference.
The LLLT group received 12 sessions of diode laser therapy (980 nm wavelength, 0.3 W power), applied in contact mode to six points bilaterally on the masseter and temporalis muscles, twice weekly over 8 weeks. The occlusal splint group wore a custom-fabricated hard acrylic mandibular splint, approximately 2 mm thick, nightly for 8 weeks.
The primary outcome was maximum bite force, measured bilaterally using a digital bite force sensor at baseline and after 8 weeks. Secondary outcomes included pain intensity, assessed using the Visual Analog Scale, and treatment satisfaction, assessed separately for parents and children using Likert-type scales.
Allocation of the 20 children with bruxism was by computer-generated randomization, with the sequence concealed from the investigator responsible for outcome assessment. Given the physical differences between the two interventions, full blinding of participants and the treating clinician was not feasible.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| LLLT | Experimental | Device: Low-Level Laser Therapy (LLLT) | 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 |
| Occlusal Splint | Active comparator | Device: Occlusal Splint | Children with sleep bruxism wore a custom hard mandibular occlusal splint nightly for 8 weeks. |
| Control | No intervention | Bruxism-free children assessed only at baseline, used as a normative reference for bite force. No treatment was given |
Sex: All, ages: 6 Years to 12 Years, accepts healthy volunteers
Inclusion Criteria: * Age 6 to 12 years * Medically healthy * Parental or legal guardian approval with signed informed consent * LLLT and occlusal splint groups: diagnosis of bruxism based on parental report * LLLT and occlusal splint groups: evidence of attrition (tooth wear) affecting primary and/or permanent dentition * Control group: no clinical signs or symptoms of bruxism, and any needed dental treatment completed Exclusion Criteria: * Use of medications such as muscle relaxants * Presence of temporomandibular joint disorders * Ongoing or previous treatment for bruxism * Associated neurological disorders * Cognitive impairments that interfere with understanding or cooperation during evaluation procedures
| Facility | City | Country | Status |
|---|---|---|---|
| Faculty of Dentistry, Ain Shams University | Cairo | Egypt |