Sleep Clinical Trial
— bruxismOfficial title:
The Effect of Occlusal Splint Type on Sleep Quality and Occlusal Force in Patients With Sleep Bruxism
NCT number | NCT04934449 |
Other study ID # | 1299 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 6, 2021 |
Est. completion date | December 14, 2021 |
Verified date | June 2022 |
Source | Istanbul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 14, 2021 |
Est. primary completion date | December 12, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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, |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul university,Faculty of Dentistry | Fatih |
Lead Sponsor | Collaborator |
---|---|
Istanbul University |
Turkey,
Rosar JV, Barbosa TS, Dias IOV, Kobayashi FY, Costa YM, Gavião MBD, Bonjardim LR, Castelo PM. Effect of interocclusal appliance on bite force, sleep quality, salivary cortisol levels and signs and symptoms of temporomandibular dysfunction in adults with sleep bruxism. Arch Oral Biol. 2017 Oct;82:62-70. doi: 10.1016/j.archoralbio.2017.05.018. Epub 2017 May 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sleep quality | Evaluating sleep quality with Pittsburgh sleep quality index | 2 months | |
Primary | occlusal force | Measuring maximum occlusal force by using digital gnatodynanometer | 2 months |
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