BruxismNCT07865845
Low-Level Laser Therapy Versus Occlusal Splint Therapy for Bruxism in Children
A study testing Low-Level Laser Therapy (LLLT) and Occlusal Splint in people with Bruxism and Sleep Bruxism, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Sleep Bruxism
- What is being tested?
- Low-Level Laser Therapy (LLLT) and Occlusal Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 13 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Low-Level Laser Therapy Versus Occlusal Splint Therapy in the Management of Bruxism in Children: A Randomized Controlled Trial
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.
Read more
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.
Read the 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.
- Conditions
- Bruxism, Sleep Bruxism
- Being tested
- Low-Level Laser Therapy (LLLT), Occlusal Splint
- Keywords
- Temporomandibular Muscles, Photobiomodulation, Occlusal Splint, Bite Force, Low-Level Laser Therapy, LLLT, Children, Pediatric Dentistry
- Medical subject headings
- Bruxism, Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 SplintDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: 8 weeks (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 May 2025
- Primary completion1 May 2026
- Study completion13 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865845
- Sponsor's protocol ID
- FDASU-REC IM022430
- Status last verified
- Feb 2024
- First submitted
- 5 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Low-Level Laser Therapy Versus Occlusal Splint Therapy in the Management of Bruxism in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07865845
- Acronym / sponsor ID
- FDASU-REC IM022430
- Conditions
- Bruxism, Sleep Bruxism
- Keywords
- Temporomandibular Muscles, Photobiomodulation, Occlusal Splint, Bite Force, Low-Level Laser Therapy, LLLT, Children, Pediatric Dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 13 Jun 2026 (actual)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 SplintChildren 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Level Laser Therapy (LLLT)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 | Device | LLLT |
| Occlusal SplintCustom-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 | Device | Occlusal Splint |
Primary outcome
Change in Bite Force
Time frame: 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.
3 secondary outcomes
Change in Pain Intensity
Time frame: Baseline and 8 weeks
Parental Satisfaction with Treatment
Time frame: 8 weeks (end of treatment)
Child Satisfaction with Treatment
Time frame: 8 weeks (end of treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Therapy (LLLT) and Occlusal Splint in people with Bruxism and Sleep Bruxism, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bite Force (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.