Comparison of a novel teeth-protecting mouthpiece with a traditional device in preventing endoscopy-related complications involving teeth or temporomandibular joint: a multicenter randomized trial.

Background and Study Aims: After upper endoscopy, patients have complained of symptoms involving teeth or the temporomandibular joint; however, these endoscopy-related complications are usually ignored with few attempts to prevent them. The aim of this study was to identify the incidence of endoscopy-related complications involving teeth or temporomandibular joint, and to compare the effectiveness of a newly developed teeth-protecting mouthpiece (TPM) with a traditional mouthpiece (the MB-142) in preventing these complications.
Patients and Methods: 872 patients from 28 centers, who were undergoing their first upper endoscopy, were randomly assigned to TPM and MB-142 groups. At 3 - 4 days after the procedure, the occurrence of endoscopy-related complications involving the teeth or the temporomandibular joint was investigated using a structured questionnaire. Finally 865 patients (TPM group, n = 423; MB-142, n = 442) responded to this questionnaire and were included in the analysis.
Results: Overall, the incidence of complications was significantly lower in the TPM than in the MB-142 group (0.9% vs. 3.2%). With stratification according to sedation status, in nonsedated patients no significant difference was found between the two groups (0.7% vs. 0.9%). In sedated patients, however, the TPM group showed a significantly lower incidence of complication than the MB-142 group (1.7% vs. 11.6%). Clinically serious problems such as a tooth fracture or a loose tooth occurred only in sedated patients in the MB-142 group.
Conclusions: The TPM showed an advantage over the MB-142 mouthpiece for preventing endoscopy-related complications involving teeth or the temporomandibular joint.