A Protective Effect of Newly Developed Silicon-Covered Two Piece-Designed Teeth Protective Mouthpiece (TPM™) On Upper Endoscopy: A Multicenter Randomised Controlled Trial

Abstract

Backgrounds: Considerable number of patients has suffered from a variety of symptoms associated with stress load on temporomandibular joint or teeth after upper endoscopy. Nevertheless, the endoscopy-induced problem tends to be unnoticed, and there have been few attempts to improve this post-endoscopic problem. The objective of this study was to investigate the efficacy of newly developed silicon-covered two piece-designed teeth protective mouthpiece (TPM™, TNO, Korea) when it was compared with that of hard typed nonflexible plastic mouthpiece (MB-142™, Olympus, Japan). Methods: 1068 patients from 28 university hospitals were randomized to either groups having TPM™ (TPM group, n = 572) or MB-142™ (MB group, n = 596). After upper endoscopic examination, all patients completed a structured questionnaire on satisfaction at mouthpiece in association with symptom or sign of temporomandibular joint disorder or teeth problem. Results: There was no difference on factors such as age, gender, presence of dentures, malocclusion, past history of upper endoscopic experience, endoscopy under sedation, and time of proceeding. Mouthpiece-associated adverse events occurred in 1 patient (0.02%) with TPM and 10 patients (1.68%) with MB (p = .001). One adverse event of TPM patient was mild toothache. On the contrary, post-endoscopic symptoms reported from MB group were severe masticatory pain, crepitus, masticatory myalgia, which were mostly serious problem. Furthermore, two catastrophic complications, which were one case of broken tooth with fragmented mouthpiece and one case of loose tooth, developed in two patients with MB. On visual analogue scale, TPM group showed higher satisfaction score compared with that of MB group (8.32 ± 0.12 vs. 8.13 ± 0.09, p = .013). Conclusions: Newly developed TPM™ gives a more protective efficacy in association with temporomandibular joint or teeth compared with hard typed nonflexible plastic mouthpiece, presenting more superior patients' satisfaction.