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: 2025-12-24 @ 10:14 PM
Ignite Modification Date: 2025-12-25 @ 7:48 PM
NCT ID: NCT04739735
Description: The present study aims to assess the children's behavioural experience while performing a routine dental procedure. There is no risk in any of the clinical interventions. Furthermore, the participants randomly selected should meet the eligibility criteria which includes a completely normal healthy patient with score ASA I in the American Society of Anesthesiologists scale.
Frequency Threshold: 0
Time Frame: 4 months
Study: NCT04739735
Study Brief: Computer - Controlled Intraligamentary Local Anaesthesia In Extraction of Primary Molars
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA) CC-ILA will be administered using the Wand-STA system according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted mandibular teeth. Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously 0 None 0 25 0 25 View
Conventional Injection of Inferior Alveolar Nerve Block * In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will be used supplemented with long buccal infiltration for the buccal gingiva. * A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed between the two primary molars on the opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly lower until bony resistance is met. Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. Two-thirds the needle length should be inserted. The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously 0 None 0 25 8 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
lip/cheek biting NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View