A New Approach for Controlling Hemostasis During Canal Tr... | NCT03060486

NCT03060486

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HYBENX®	Experimental	1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec	Device: HYBENX®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HYBENX®	Device	The mixture was then introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement. Finally, the canal was rinsed with sterile saline water using a syringe with a side-vented 30 G needle.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Root Canal Bleeding Score	After the root canal, shaping was performed, and a first sterile paper point was introduced in the root canal, up to the working length, to detect blood presence. The root canal bleeding score (RCBS) was given as follows: 0: no blood detected 1: blood detected in the apical third of the root canal 2: blood detected both in the apical and the middle thirds of the root canal 3: blood detected in the whole root canal. After the use of the material a second sterile paper point was introduced in the root canal, up to the working length, to detect the presence of blood and an RCBS was assessed according the previous criteria	20 sec - before and after use

Eligibility Module

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	HYBENX®	1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec HYBENX®: The mixture was then introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement. Finally, the canal was rinsed with sterile saline water using a syringe with a side-vented 30 G needle.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	HYBENX®	1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec HYBENX®: The mixture was then introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement. Finally, the canal was rinsed with sterile saline water using a syringe with a side-vented 30 G needle.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Root Canal Bleeding Score

After the root canal, shaping was performed, and a first sterile paper point was introduced in the root canal, up to the working length, to detect blood presence.

The root canal bleeding score (RCBS) was given as follows:

0: no blood detected
1: blood detected in the apical third of the root canal
2: blood detected both in the apical and the middle thirds of the root canal
3: blood detected in the whole root canal. After the use of the material a second sterile paper point was introduced in the root canal, up to the working length, to detect the presence of blood and an RCBS was assessed according the previous criteria

Posted

Mean

Standard Deviation

score on a scale

20 sec - before and after use

teeth

ID	Title	Description
OG000	HYBENX®	1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec HYBENX®: The mixture was then introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement. Finally, the canal was rinsed with sterile saline water using a syringe with a side-vented 30 G needle.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	HYBENX®	1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec HYBENX®: The mixture was then introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement. Finally, the canal was rinsed with sterile saline water using a syringe with a side-vented 30 G needle.

More Info Module

Certain Agreements