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

NCT07865845 — Not applicable, Completed, 30 participants, Ain Shams University

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Evaluation of Low-Level Laser Therapy Versus Occlusal Splint Therapy in the Management of Bruxism in Children: A Randomized Controlled Trial

RegistryNCT07865845
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment30 (Actual)
SponsorAin Shams University (Other)
ConditionsBruxism, Sleep Bruxism
InterventionsLow-Level Laser Therapy (LLLT), Occlusal Splint (Device)
Datesstart 2025-05-01, primary completion 2026-05-01, completion 2026-06-13, first posted 2026-10-08, last updated 2026-10-16
Locations1 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

-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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
LLLTExperimentalDevice: 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 SplintActive comparatorDevice: Occlusal SplintChildren with sleep bruxism wore a custom hard mandibular occlusal splint nightly for 8 weeks.
ControlNo interventionBruxism-free children assessed only at baseline, used as a normative reference for bite force. No treatment was given
  • 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
  • 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

+Outcome measures

Primary outcomes

  • Change in Bite Force [Baseline and 8 weeks]: Maximum bite force on the right side, the left side, and the average of both sides, measured with the iBite digital bite force sensor and recorded in newtons. The highest of three consecutive measurements on each side was used. Higher values indicate a stronger bite force.

Secondary outcomes

  • Change in Pain Intensity [Baseline and 8 weeks]: Pain related to jaw muscle activity, rated by the child (with caregiver help when needed) on the Visual Analog Scale, a 10-centimeter line with facial expressions scored 0, 2, 4, 6, 8, and 10. Minimum value is 0 (smiling face, no pain); maximum value is 10 (crying face, most severe pain). Higher scores indicate worse pain.
  • Parental Satisfaction with Treatment [8 weeks (end of treatment)]: Parental satisfaction with and acceptance of the treatment, including perceived effectiveness, comfort, and overall acceptability, rated by the caregiver at the end of treatment on a five-point Likert scale. Minimum value is 1 (very dissatisfied); maximum value is 5 (very satisfied). Higher scores indicate greater satisfaction (a better outcome).
  • Child Satisfaction with Treatment [8 weeks (end of treatment)]: Child satisfaction, comfort during the procedure, and acceptance of the treatment, rated at the end of treatment on a structured 3-point Likert scale (1 = dissatisfied, 2 = neutral, 3 = satisfied). Completed by the child with help from the caregiver if needed. Higher scores indicate greater satisfaction, comfort, and acceptance.

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Faculty of Dentistry, Ain Shams UniversityCairoEgypt