Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group 5 (SWEEPS) | A Fotona Er:YAG laser device (SWEEPS 600, Fotona) with an 8.5 mm long and 600 µm diameter tapered fiber tip was used for activation. The device was set to SWEEPS mode with two ultrashort micropulses (25 μs) continuously changing at 0.3 W, 20 mJ, and 15 Hz. The tip was placed in the pulp chamber, and the solution was activated with the air and water settings turned off. | 0 | None | 0 | 22 | 0 | 22 | View |
| Control Group (Conventional Syringe Irrigation) | In this group, the traditional syringe method was used for final irrigation of the root canals. The canals were irrigated with 6 mL of 17% EDTA solution, 2 mL of saline and, finally, 6 mL of 2.5% NaOCl, and a 30-gauge perforated irrigation needle placed 1-2 mm shorter than the working length was used. During irrigation, 1-2 mm updown movements were made with a constant low pressure. | 0 | None | 0 | 22 | 0 | 22 | View |
| Group 1 (MDA) | After the root canal was filled with irrigation solution, a gutta-percha cone compatible with the master file was positioned 1 mm behind the working length and moved up and down with 100 strokes/minute for activation. | 0 | None | 0 | 22 | 0 | 22 | View |
| Group 2 (Sonic Activation) | Sonic activation was performed via the Easydo Activator device (EA; Easyinsmile (Weixiaomeichi, Changsha, China). While the solution was present in the canal, the needle tip of the device was placed in the canal 2 mm behind the determined working length, and the solutions were activated at the recommended power setting. | 0 | None | 0 | 22 | 0 | 22 | View |
| Group 3 (PUI) | Solutions were activated via ultrasonic tips (mode:E, setting:6) (DTE, Guilin Woodpecker Co., Guilin, Guangxi, China) and an ultrasonic device (DTE S6 Led, Guilin Woodpecker Co., Guilin, Guangxi, China). An ultrasonic tip one size smaller than the master apical file was used 2 mm behind the working length without contacting the walls. | 0 | None | 0 | 22 | 0 | 22 | View |
| Group 4 (PIPS) | A Fotona Er:YAG laser device (LightWalker Fotona, Ljubljana, Slovenia) was used for activation. A special conical and radial fiber tip (PIPS 300/14, Fotona) was placed in the coronal part of the pulp chamber, and the irrigation solutions in the canal were activated in SSP mode (50 μs, 0.3 W, 15 Hz and 20 mJ) with the air and water settings turned off. | 0 | None | 0 | 22 | 0 | 22 | View |