| Methods |
Randomised controlled cross‐over study; patients, data extractors and data analysis were blinded; 1 week washout period between treatments. |
| Participants |
13 severe bruxers (9 females and 4 males), age mean of 24 years; history of tooth grinding for at least 3 nights per week and polygraphic confirmation of a minimum of 4 episodes of sleep bruxism per hour of sleep and a minimum of 2 episodes with tooth grinding sound. Participants with pain, neurological or sleep disorders, missing more than 2 posterior teeth, using medication, drug or alcohol were excluded from the study. Also were excluded those who had been treated with any type of oral device in the preceding 6 months, those wearing a dental prothesis, or presenting gross malocclusion. |
| Interventions |
Group A: Occlusal splint (n = 13).
Group B: Mandibular advancement device in 25% advancement position (n = 13).
Group C: Mandibular advancement device in 75% advancement position (n = 13).
Group D: Mandibular advancement device free (n = 13), 2 weeks of treatment duration. |
| Outcomes |
Sleep bruxism episodes per hour of sleep; sleep latency; number of orofacial activities; pain during the night; oral dryness; comfort; preference. |
| 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; 3) some results are presented in results section; 4) the abstract entitled 'Effect of double arch device and occlusal splint in sleep bruxism patients' is the same study as 'Reduction of sleep bruxism using a mandibular advancement device: an experimental controlled study' with full results. Some data could not be obtained because they are reported inappropriately. Setting: Patients were recruited by advertisement at the Montreal city universities and colleges (Canada). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
