CompletedNot Applicable

Occlusal Splints in the Treatment of Sleep Bruxism

Turkey (Türkiye)100 participantsStarted 2021-08-06

Plain-language summary

Occlusal splints are employed in the treatment of sleep bruxism. These appliances decrease sleep-related actions and damages bruxism, like grinding, tooth-wear, headache, and temporomandibular joint disorders. Occlusal splints are produced both in hard and soft forms according to the used material. In this study, it was aimed to evaluate the effect of occlusal splint type on the sleep quality and occlusal force parameters of patients with sleep bruxism.

Who can participate

Age range

18 Years – 65 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: \- Healthy participants with complete permanent dentition. Exclusion Criteria: * Presence of a systemic disorder that could compromise the masticatory system (e.g., neurological disorders, epilepsy, cerebral palsy, among others), * Systemic disorder or current use of drugs that could interfere, directly or indirectly, with muscle activity, * Inappropriate behavior and/or refusal to cooperate with dental procedures and data collection, * Tooth loss (except for third molars), * Soft tissue abnormalities, * Toothache report, * Active periodontitis (presence of periodontal pockets involvement of the supporting tissues), * Caries lesions, * Use of orthodontic appliances, * Use of dental prosthesis (fixed or removable partial). * Subjects with moderate to severe malocclusions, diagnosed by using the Orthodontic Treatment Need Index (IOTN) (scores 5 or 6 - severe and extreme need for orthodontic treatment) * Alcohol or drug abuse,

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

Sleep quality

Timeframe: 2 months

occlusal force

Timeframe: 2 months

Trial details

NCT IDNCT04934449

SponsorIstanbul University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-12

View on ClinicalTrials.gov More Sleep Bruxism, Adult trials