Repeated Botulinum Toxin Type A Injections on Intramuscular Fat Accumulation in Individuals With … (NCT07266064) | Clinical Trial Compass
CompletedNot Applicable
Repeated Botulinum Toxin Type A Injections on Intramuscular Fat Accumulation in Individuals With Sleep Bruxism.
Turkey (Türkiye)27 participantsStarted 2024-01-02
Plain-language summary
This study investigates whether repeated botulinum toxin type A (BoNT-A) injections used to manage sleep bruxism lead to structural changes-specifically intramuscular fat accumulation-in the masseter muscle. Adults with probable sleep bruxism receive BoNT-A injections every six months and undergo ultrasound evaluations before each injection. By tracking fat percentage in the masseter muscle over multiple treatment cycles, the study aims to determine whether long-term BoNT-A use causes progressive structural alterations or remains safe for repeated clinical use.
Who can participate
Age range
18 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:
* Adults aged 18 years or older.
* Clinical diagnosis of probable sleep bruxism according to the international consensus criteria proposed by Lobbezoo et al.
* Indication for BoNT-A injection in the masseter muscle due to bruxism-related pain or muscle hypertrophy.
* Willingness to undergo repeated BoNT-A injections at six-month intervals.
* Willingness to participate in ultrasonographic evaluations at each follow-up visit.
Exclusion Criteria:
* Presence of neurological or neuromuscular disorders affecting the masticatory muscles (e.g., dystonia, myasthenia gravis).
* History of orofacial trauma, temporomandibular joint dysfunction, or maxillofacial surgery.
* Systemic diseases that may affect neuromuscular transmission or muscle metabolism.
* Use of medications known to interfere with neuromuscular function, including aminoglycoside antibiotics or corticosteroids.
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.