BruxismRCSNCT06131879
Laser Versus Physiotherapy in Management of Bruxism in Children: RCS
A study testing Laser acupuncture and Modified physical therapy in people with Bruxism, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
The goal of this randomized controlled study is to compare laser acupuncture versus modified physical therapy in controlling bruxism in children. The main questions aim to answer are: Laser will decrease tempro-mandibular joint pain from bruxism more than modified physical therapy? Laser will decrease muscles activity… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism
- What is being tested?
- Laser acupuncture and Modified physical therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Aug 2023to 19 Oct 2023
- 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
- Six to twelve years children
- Medically free
- Normal occlusion
- No or low caries experience
- Clinical dental wear
- Clenching or grinding reported by the parents
Who cannot join
- Children with any physical or psychological disease.
- Children received any previous treatment for bruxism.
- Children with tempro-mandibular joint disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Laser Acupuncture Versus Modified Physical Therapy Intervention in Management of Bruxism in Children, Study Protocol for a Randomized Controlled Study
The goal of this randomized controlled study is to compare laser acupuncture versus modified physical therapy in controlling bruxism in children. The main questions aim to answer are:
- Laser will decrease tempro-mandibular joint pain from bruxism more than modified physical therapy?
- Laser will decrease muscles activity from bruxism more than modified physical therapy? Children took 6 sessions of either laser acupuncture or modified physical therapy Researchers compared laser acupuncture versus modified physical therapy to see if any decrease in tempro-mandibular joint pain and muscles activity from bruxism
Read the detailed description
The children participated in the study as bruxers according to the American Association of Sleep Medicine (AASM) diagnostic criteria [ Sixteen children will be randomly allocated to two groups of 8 individuals each: Group one: laser acupuncture, Group two: electromyography biofeedback training.
Pain will be measured by Visual Analogue scale; VAS (primary outcome)and muscle activity will be measured by Electromyography (Secondary outcome) of temporalis and masseter muscles. Measurements will be taken preoperatively and after 8 weeks.
- Conditions
- Bruxism
- Being tested
- Laser acupuncture, Modified physical therapy
- Keywords
- bruxism, laser, children, Physiotherapy
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupunctureDevice
Also called Doctor smile low level laser device
Biostimulation of temporalis and masseter muscles
Modified physical therapyBehavioural
Also called Relaxation and biofeedback of muscles
Progressive muscle relaxation of temporalis and masseter muscles
| Study group | Role | What they receive |
|---|---|---|
| Laser acupuncture | Experimental | Laser acupuncture biostimulation for temporalis and masseter muscles Receives: Device: Laser acupuncture |
| Modified physical therapy | Experimental | Muscle relaxation and biofeedback for temporalis and masseter muscles Receives: Behavioral: Modified physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tempro-mandibular joint pain
Tenderness and pain of temporalis and masseter muscles by visual analogue scale (VAS) of pain before and after intervention either no pain, mild pain, moderate or severe pain. Better outcome means no or mild pain
Measured: 2 months
Secondary outcomes (1)
Activity of temporalis and masseter muscles
Activity of temporalis and masseter muscles by surface electromyography (EMG) at rest and during function (Decrease in activity by small values bymicrons means better outcome and vice versa)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start22 Aug 2023
- Primary completion15 Sep 2023
- Study completion19 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BruxismStudies of the same condition, open and under way.
- 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
- Randomized double arm controlled study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Farouk Rashed, National Research Centre, Egypt
- Investigators
- Mohamed F Rashed, Researcher, Principal investigator, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131879
- Sponsor's protocol ID
- 4-4-3
- Acronym
- RCS
- Status last verified
- Nov 2023
- First submitted
- 20 Oct 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share results
Publications
Rashed MF, Mohamed MA, Mohamed NER, Mansy ME. Evaluation of laser acupuncture versus physical therapy intervention in management of bruxism in children: a randomized controlled trial. BMC Oral Health. 2025 Mar 5;25(1):341. doi: 10.1186/s12903-025-05626-x.
PubMed 40045349
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Laser Acupuncture Versus Modified Physical Therapy Intervention in Management of Bruxism in Children, Study Protocol for a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06131879
- Acronym / sponsor ID
- RCS / 4-4-3
- Conditions
- Bruxism
- Keywords
- bruxism, laser, children, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 14 Nov 2023 (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.
The goal of this randomized controlled study is to compare laser acupuncture versus modified physical therapy in controlling bruxism in children. The main questions aim to answer are:
- Laser will decrease tempro-mandibular joint pain from bruxism more than modified physical therapy?
- Laser will decrease muscles activity from bruxism more than modified physical therapy? Children took 6 sessions of either laser acupuncture or modified physical therapy Researchers compared laser acupuncture versus modified physical therapy to see if any decrease in tempro-mandibular joint pain and muscles activity from bruxism
Detailed description
The children participated in the study as bruxers according to the American Association of Sleep Medicine (AASM) diagnostic criteria [ Sixteen children will be randomly allocated to two groups of 8 individuals each: Group one: laser acupuncture, Group two: electromyography biofeedback training.
Pain will be measured by Visual Analogue scale; VAS (primary outcome)and muscle activity will be measured by Electromyography (Secondary outcome) of temporalis and masseter muscles. Measurements will be taken preoperatively and after 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double arm controlled study
| Arm | Type | Receives |
|---|---|---|
| Laser acupuncture | Experimental | Device: Laser acupunctureLaser acupuncture biostimulation for temporalis and masseter muscles |
| Modified physical therapy | Experimental | Behavioral: Modified physical therapyMuscle relaxation and biofeedback for temporalis and masseter muscles |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Six to twelve years children
- Medically free
- Normal occlusion
- No or low caries experience
- Clinical dental wear
Key exclusion criteria (3 listed)
- Children with any physical or psychological disease.
- Children received any previous treatment for bruxism.
- Children with tempro-mandibular joint disorders
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 |
|---|---|---|
| Laser acupunctureAlso: Doctor smile low level laser deviceBiostimulation of temporalis and masseter muscles | Device | Laser acupuncture |
| Modified physical therapyAlso: Relaxation and biofeedback of musclesProgressive muscle relaxation of temporalis and masseter muscles | Behavioural | Modified physical therapy |
Primary outcome
Tempro-mandibular joint pain
Time frame: 2 months
Tenderness and pain of temporalis and masseter muscles by visual analogue scale (VAS) of pain before and after intervention either no pain, mild pain, moderate or severe pain. Better outcome means no or mild pain
1 secondary outcome
Activity of temporalis and masseter muscles
Time frame: 2 months
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 14 Nov 2023.
- Derived from this study: PubMed 40045349Rashed MF, Mohamed MA, Mohamed NER, Mansy ME. Evaluation of laser acupuncture versus physical therapy intervention in management of bruxism in children: a randomized controlled trial. BMC Oral Health. 2025 Mar 5;25(1):341. doi: 10.1186/s12903-025-05626-x.
- Individual participant dataSharing planned: No. No plan to share results
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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.
Mohamed F Rashed, Researcher principal investigator
National Research Centre, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture and Modified physical therapy in people with Bruxism, run by National Research Centre, Egypt 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 3 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 14 Nov 2023. 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?
Tempro-mandibular joint pain (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06131879, which also lists 1 linked publication.
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 14 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.