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.
OBJECTIVE
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.


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.
Department of Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea.
B-H
BH
Min
H
H
Lee
J S
JS
Jeong
H J
HJ
Son
J J
JJ
Kim
J C
JC
Rhee
P-L
PL
Rhee
Y B
YB
Yoon
D000328:Adult; D000368:Aged; D016145:Endoscopy, Digestive System / Q000009:adverse effects* / Q000379:methods; D004867:Equipment Design; D004869:Equipment Safety; D004945:Esophagoscopy / Q000009:adverse effects / Q000379:methods; D005773:Gastroscopy / Q000009:adverse effects / Q000379:methods; D006801:Humans; D008875:Middle Aged; D009064:Mouth Protectors / Q000592:standards* / Q000706:statistics & numerical data; D012016:Reference Values; D012680:Sensitivity and Specificity; D013705:Temporomandibular Joint Disorders / Q000209:etiology / Q000517:prevention & control*; D013718:Tensile Strength; D014076:Tooth Diseases / Q000209:etiology / Q000517:prevention & control*