Study design
TMD, bleeding, pulp pain, periodontitis, pain, tooth
ADVERSE REACTIONS, DENTAL CARIES, BLEEDING, MUCOSAL DISEASE, PERIODONTITIS, CAVITY
This study was a single-blind, multi-center (Tohoku University Hospital and Otemachi Kawata Dental Clinic) randomized controlled trial with a split-mouth design to compare the effect of PJD and TMD treatments. The protocol was reviewed and approved by the Institutional Review Board of Tohoku University Hospital (reference No. 163,006). In addition, this study and the clinical trial was performed in accordance with the Declaration of Helsinki, the Consolidates Standards of Reporting Trials (CONSORT), and the Good Clinical Practice (GCP) guideline. Before starting this study, we consulted the Pharmaceutical and Medical Device Agency, a regulatory authority in Japan, and obtained clinical trial notifications. The clinical trial was registered on the University hospital Medical Information Network (ID: UMIN000025022. date of first registration: 02/12/2016).The patient inclusion criteria were as follows: (1) age ≥ 20 years; (2) informed consent signed by the patient; (3) subjects who were able to visit the hospital throughout the clinical trial period; (4) presence of DH symptoms in two or more quadrants with a visual analog scale (VAS) score of 30 mm or larger when air is applied at a pressure of 0.4 ± 0.05 MPa and a flow rate of 15 ± 3 L / min; and (5) subjects who agreed not to receive DH treatment until completion of the clinical trial even if they had DH symptoms in a tooth adjacent to the test tooth. The exclusion criteria were as follows: (1) presence of oral mucosal disease; (2) medical history of adverse reactions to local anesthesia; (3) pregnancy or possibility thereof; (4) participating in another clinical trial; (5) having other pain in an oral cavity; (6) taking pain medication; (7) subjects considered unsuitable for the trial by the investigators; and (8) presence of dental caries, pulp pain, or periodontitis with a probing pocket depth of ≥ 5 mm and bleeding on probing in a test quadrant.