Adverse Events Module

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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

Ignite Creation Date: 2025-12-26 @ 11:11 AM
Ignite Modification Date: 2025-12-26 @ 11:11 AM
NCT ID: NCT03127228
Description: The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT03127228
Study Brief: Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard Mechanical Debridement Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers. Standard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy 0 None 0 12 6 12 View
Er:YAG Laser-assisted Debridement Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment. Standard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy Er:YAG laser-assisted debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy 0 None 0 12 3 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinus Tract Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tooth pain SYSTEMATIC_ASSESSMENT General disorders None View
Flu SYSTEMATIC_ASSESSMENT Infections and infestations None View
Jaw discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Broken filling SYSTEMATIC_ASSESSMENT General disorders None View
Shoulder Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fistula SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ulcer on ear SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Residual suture SYSTEMATIC_ASSESSMENT General disorders None View
Shingles SYSTEMATIC_ASSESSMENT Immune system disorders None View
Crown off SYSTEMATIC_ASSESSMENT General disorders None View
Type 2 Diabetes SYSTEMATIC_ASSESSMENT Immune system disorders None View