BruxismNCT07548502
Effect of Night Guard Use on Masseter Muscle Thickness in Children With Bruxism
A study testing Occlusal Splint (Night Guard) in people with Bruxism and Bruxism, Sleep-Related, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
This prospective study aims to evaluate the clinical findings of bruxism and masseter muscle thickness in children aged 10-12 years using ultrasonography, and to assess the effects of night guard use on these parameters over time. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Bruxism, Sleep-Related
- What is being tested?
- Occlusal Splint (Night Guard)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 10-12 years
- Diagnosis of bruxism based on parental report and clinical findings
- Willingness to participate
- Parental consent and child assent obtained
Who cannot join
- Missing posterior teeth causing unilateral chewing
- History of psychological disorders
- Neurological disorders or craniofacial abnormalities
- Use of medications affecting muscle activity
- Presence of skeletal malocclusions
- Ongoing orthodontic treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Niğde Ömer Halisdemir University Faculty of Dentistry
Niğde
Merdan Doğan, +905422076565, merdan@ohu.edu.tr
About this study
Official title: Ultrasonographic Assessment of Masseter Muscles in Pediatric Bruxism: Effects of Night Guard Therapy at 3 and 6 Month Intervals
This prospective study aims to evaluate the clinical findings of bruxism and masseter muscle thickness in children aged 10-12 years using ultrasonography, and to assess the effects of night guard use on these parameters over time.
Read the detailed description
This prospective, single-group follow-up study is designed to evaluate the effects of night guard use on bruxism symptoms and masseter muscle thickness in children aged 10-12 years. A total of 20 children diagnosed with bruxism based on parental reports and clinical examination will be included. Clinical findings, including tooth wear, muscle tenderness, temporomandibular joint findings, and parafunctional habits, will be recorded.
Masseter muscle thickness will be measured bilaterally using ultrasonography under standardized conditions at baseline, 3 months, and 6 months. Following baseline evaluation, a custom-made night guard will be fabricated for each participant and regular use will be recommended.
Changes in clinical symptoms and muscle thickness over time will be analyzed. Ultrasonographic measurements will be performed using a standardized protocol by an experienced dentomaxillofacial radiologist. The study does not include a control group. All procedures are non-invasive and do not involve ionizing radiation.
- Conditions
- Bruxism, Bruxism, Sleep-Related
- Being tested
- Occlusal Splint (Night Guard)
- Keywords
- Pediatric bruxism, Masseter muscle thickness, Ultrasonography, Night Guard
- 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.
Occlusal Splint (Night Guard)Device
Participants will receive a custom-made night guard and will be instructed to use it regularly during sleep.
| Study group | Role | What they receive |
|---|---|---|
| Night Guard Treatment | Experimental | Not described Receives: Device: Occlusal Splint (Night Guard) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in masseter muscle thickness
Change in masseter muscle thickness (measured by ultrasonography)
Measured: Baseline, 3 months, 6 months
Secondary outcomes (2)
Change in bruxism-related clinical symptoms assessed by Wong-Baker Faces Pain Rating Scale
Changes in bruxism-related symptoms including muscle pain, fatigue, and headache will be assessed using a Wong-Baker Faces Pain Rating Scale (WBFPRS). The WBFPRS consists of a scale ranging from 0 (no hurt) to 10 (hurt worst). Higher scores indicate greater symptom severity.
Measured: Baseline, 3 months, 6 months
Change in temporomandibular joint (TMJ) clinical findings (joint sounds, deviation/deflection, pain on palpation)
Temporomandibular joint (TMJ) findings will be assessed by clinical examination, including the presence of joint sounds (clicking/crepitation), mandibular deviation or deflection during opening, and pain on palpation. Each finding will be recorded as present or absent. The number of positive findings per participant will be calculated, with higher values indicating greater TMJ involvement.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start15 Mar 2026
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548502
- Sponsor's protocol ID
- NigdeOHU-BruksizmUSG
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Assessment of Masseter Muscles in Pediatric Bruxism: Effects of Night Guard Therapy at 3 and 6 Month Intervals
- ClinicalTrials.gov ID
- NCT07548502
- Acronym / sponsor ID
- NigdeOHU-BruksizmUSG
- Conditions
- Bruxism, Bruxism, Sleep-Related
- Keywords
- Pediatric bruxism, Masseter muscle thickness, Ultrasonography, Night Guard
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 Apr 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.
This prospective study aims to evaluate the clinical findings of bruxism and masseter muscle thickness in children aged 10-12 years using ultrasonography, and to assess the effects of night guard use on these parameters over time.
Detailed description
This prospective, single-group follow-up study is designed to evaluate the effects of night guard use on bruxism symptoms and masseter muscle thickness in children aged 10-12 years. A total of 20 children diagnosed with bruxism based on parental reports and clinical examination will be included. Clinical findings, including tooth wear, muscle tenderness, temporomandibular joint findings, and parafunctional habits, will be recorded.
Masseter muscle thickness will be measured bilaterally using ultrasonography under standardized conditions at baseline, 3 months, and 6 months. Following baseline evaluation, a custom-made night guard will be fabricated for each participant and regular use will be recommended.
Changes in clinical symptoms and muscle thickness over time will be analyzed. Ultrasonographic measurements will be performed using a standardized protocol by an experienced dentomaxillofacial radiologist. The study does not include a control group. All procedures are non-invasive and do not involve ionizing radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Night Guard Treatment | Experimental | Device: Occlusal Splint (Night Guard) |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 10-12 years
- Diagnosis of bruxism based on parental report and clinical findings
- Willingness to participate
- Parental consent and child assent obtained
Key exclusion criteria (6 listed)
- Missing posterior teeth causing unilateral chewing
- History of psychological disorders
- Neurological disorders or craniofacial abnormalities
- Use of medications affecting muscle activity
- Presence of skeletal malocclusions
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 |
|---|---|---|
| Occlusal Splint (Night Guard)Participants will receive a custom-made night guard and will be instructed to use it regularly during sleep. | Device | Night Guard Treatment |
Primary outcome
Change in masseter muscle thickness
Time frame: Baseline, 3 months, 6 months
Change in masseter muscle thickness (measured by ultrasonography)
2 secondary outcomes
Change in bruxism-related clinical symptoms assessed by Wong-Baker Faces Pain Rating Scale
Time frame: Baseline, 3 months, 6 months
Change in temporomandibular joint (TMJ) clinical findings (joint sounds, deviation/deflection, pain on palpation)
Time frame: Baseline, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlusal Splint (Night Guard) in people with Bruxism and Bruxism, Sleep-Related, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Apr 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aycan Dal Dönertaş (+903382252595, aycandal@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in masseter muscle thickness (time frame: Baseline, 3 months, 6 months). 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 29 Apr 2026.