Evaluation
Cancer, tooth, s.“Spontaneous pain, pain
ADVERSE EVENTS, ADVERSE EVENT, SECONDARY, CANCER
Evaluations were performed by only blinded evaluators. Operators were not involved in the evaluation. Pulp symptom (pain) caused by air application with inclusion criteria (3) was defined as “air pain” and by scratch using a dental explorer as “scratch pain.” The evaluators performed calibration before the evaluation. In case of air pain examination, air pressure and flow rate were controlled to maintain these levels using a PJD-UNIT syringe connected to an air pressure and flow rate controller. The airflow was checked chronologically using an airflow sensor. The unit syringe was held with the tip about 1 cm away from the target area, and air was applied with a pressure of 0.4 ± 0.05 MPa and a flow rate of 15 ± 3 L/min. In case of scratch pain, the evaluators were trained using a pressure gauge to ensure that the scratch force was constant. The tip of an explorer (Multi, YDM Corporation) was run with a pressure of about 20 g both ways for about 1 s.“Spontaneous pain” for each subject tooth and the presence of pain that interferes with daily life were recorded. VAS for air, scratch, spontaneous pain and gingival index (GI) were recorded by the blinded evaluators the next day, and 1, 4, 8, and 12 weeks after treatment. During the follow-up period, adverse events were recorded, and their severity was determined based on the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE), v4.0.This study’s primary endpoint was improvement rate of air pain 12 weeks after treatment. The secondary endpoint was improvement of scratch pain 12 weeks after treatment. Safety endpoints were adverse events (spontaneous pain, GI, other adverse events) and device malfunction.