An interventional study of Low-Level Laser Therapy (LLLT) and Occlusal Splint in Bruxism and Sleep Bruxism, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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.
169 studies on the registry are indexed under Bruxism; 39 are open to participants now.
This study's enrollment of 30 is below the median of 39 across 106 interventional studies indexed under Bruxism.
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Exclusion Criteria:
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)
Children with sleep bruxism wore a custom hard mandibular occlusal splint nightly for 8 weeks.
Device: Occlusal Splint
Bruxism-free children assessed only at baseline, used as a normative reference for bite force. No treatment was given
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
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
Change in Bite Force
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.
Time frame: Baseline and 8 weeks
Change in Pain Intensity
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.
Time frame: Baseline and 8 weeks
Parental Satisfaction with 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).
Time frame: 8 weeks (end of treatment)
Child Satisfaction with 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.
Time frame: 8 weeks (end of treatment)
Plan to share: Yes — De-identified individual participant data will be shared, including baseline demographic data, bite force measurements (baseline and 8 weeks), Visual Analog Scale pain scores, and parental and child satisfaction scores for all 30 participants. Data will be shared in a format suitable for independent verification and re-analysis of the study's primary and secondary outcomes.
Supporting information: Study protocol, Statistical analysis plan
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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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