CompletedNot Applicable

Ultrasonographic Evaluation of the Effect of Occlusal Splint Treatment on Masseter Muscle Thickness in Children With Sleep Bruxism:A Clinical Pilot Study

Turkey (Türkiye)11 participantsStarted 2022-02-01

Plain-language summary

The aim of this study was to evaluate the effectiveness of occlusal splint in pediatric bruxist patients by ultrasonic measurements of masseter muscle thickness and pain perception.

Who can participate

Age range

7 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Symptoms of tooth clenching or grinding when sleeping at night or during the day, including headaches in the morning, as reported by parents during anamnesis. * Attrition-type tooth wear, as well as discomfort, fatigue, and/or pain in the jaw muscles when palpated during a clinical examination. The clinical diagnosis of attrition was based on the following findings: * Shiny and flat facets. * The enamel and dentin wear at the same pace. * Wear patterns on opposing teeth's occlusal surfaces. * Possible breakage of cusps or restorations. * Impressions on the cheeks, tongue, or lips. Exclusion Criteria: * Children with any chronic/systemic/psychological disease, presence of TMD symptoms, lack of posterior teeth that may cause unilateral chewing, use of any medication that may affect muscle activity, dental malocclusions (any skeletal jaw problems in anteroposterior and vertical dimensions) and ongoing orthodontic treatment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

muscle thickness measurement

Timeframe: from the beginning to the third month

Trial details

NCT IDNCT06894342

SponsorAnkara Yildirim Beyazıt University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-28

View on ClinicalTrials.gov More Bruxism, Sleep trials

Who can participate

Age range

7 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.