Trial Outcomes & Findings for A New Approach for Controlling Hemostasis During Canal Treatment: a Pilot Study (NCT NCT03060486)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

20 sec - before and after use

Results posted on

2018-10-17

Participant Flow

Unit of analysis: Teeth

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	15 15
Overall Study COMPLETED	15 15
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A New Approach for Controlling Hemostasis During Canal Treatment: a Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HYBENX® n=15 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment Italy	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 20 sec - before and after use

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

Outcome measures

Outcome measures
Measure	HYBENX® n=15 teeth 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.
Change From Baseline in Root Canal Bleeding Score Before use	2.33 score on a scale Standard Deviation 0.724
Change From Baseline in Root Canal Bleeding Score After use	0.13 score on a scale Standard Deviation 0.352

Adverse Events

HYBENX®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Riccardo Pace, DMD

AOU Careggi

Phone: 00390557945608

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place