Van der Zaag 2005.
Methods | Controlled randomised clinical study (block randomisation); allocation concealment; patients and data extractors were blinded. | |
Participants | 21 adults (5 men, 16 women) age mean of 34.8 years (SD = ± 12.2; range = 18‐68 years); with tooth grinding sounds during sleep for at least 3 nights per week during the last 6 months reported by partner, tooth wear to at least the degree of exposed dentine (grade 2). Were excluded from this study those participants with a medical contraindication, such as epilepsy or other sleep disorder or the use of any medication with a known influence on sleep structure or SB. | |
Interventions | Group A: Occlusal splint (n = 11) with 4 men and 7 women with mean age of 34.2 years (SD = ± 13.1; range = 21‐68 years). Group B: Palatal splint (n = 10) with 1 men and 9 women with mean age of 34.9 years (SD = ± 11.2; range = 18‐55 years). They wore their splint 24 hours a day, except for eating for 4 weeks. | |
Outcomes | Number of bruxism episodes per hour of sleep; total sleep time; sleep efficiency; arousal index. | |
Notes | The following completed data were acquired by personal communication: 1) randomisation was done with a computer generated sequence; 2) sealed opaque envelope was used to perform allocation concealment. Some data could not be obtained. Setting: Participants were recruited from the Department of Oral Function, Section of Oral Kinesiology, of the Academic Centre for Dentistry in Amsterdam or the Department of Clinical Neurophysiology of the Slotervaart General Hospital in Amsterdam (Holland). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |
SD = standard deviation; TENS = transcutaneous electric nerve stimulation