An interventional study of Occlusal splint in Sleep Bruxism, Adult, Splints and Sleep, sponsored by Istanbul University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-22.
Sponsored by Istanbul University · Not applicable, Interventional, and Treatment
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.
Various splint designs have been used for the treatment of sleep bruxism that is made up of different materials: Hard and soft splints. Although, these splints have slightly different appearances and properties, in fact, scientific evidence supports both the use of hard and soft occlusal splints. Hard splints are more preferred when compared to soft ones, thus, oft appliances have been less documented in the scientific literature. However, some studies suggested the use of soft-resin splints that are easily fabricated and may be inserted at an initial appointment, dental clinicians may desire the use of soft appliances. One of the advantages of these appliances is they are easy to tolerable to the patient and comfortable. Additionally, these splints fit tightly and provide a flat plane during sleep.
Considering these advantages, the present study was designed to examine the effect of the use of different types of occlusal splints on the sleep quality and occlusal force of patients with sleep bruxism. For this purpose, the effect of two splints basically fabricated from two different materials were evaluated and compared. The null hypothesis was that the use of both occlusal splints would not change the values of sleep quality and maximum occlusal force of the patients with sleep bruxism.
166 studies on the registry are indexed under Bruxism; 38 are open to participants now.
This study's enrollment of 100 is above the median of 38 across 103 interventional studies indexed under Bruxism.
Browse Bruxism studies →Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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This group of patients was allocated to use 2 mm-thickness, hard occlusal splints for 2 months during sleep
Device: Occlusal splint
This group of patients was allocated to use 3 mm-thickness, hard occlusal splints for 2 months during sleep
Device: Occlusal splint
This group of patients was allocated to use 2 mm-thickness, soft occlusal splints for 2 months during sleep
Device: Occlusal splint
This group of patients was allocated to use 3 mm-thickness, soft occlusal splints for 2 months during sleep
Device: Occlusal splint
Using occlusal splints during sleep for 2 months
Sleep quality
Evaluating sleep quality with Pittsburgh sleep quality index
Time frame: 2 months
occlusal force
Measuring maximum occlusal force by using digital gnatodynanometer
Time frame: 2 months
Plan to share: No
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Istanbul University