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

Blood contamination, such as apical microleakage, of root canal during preparation can be a major problem in endodontics. The purpose of this investigation was to evaluate the hemostatic properties of sulfonic/sulfuric acid solution used during root canal therapy in teeth with irreversible pulpitis.

Study Overview

• Status: Completed
• Conditions: Blood Contamination of Root Canal During Endodontic Therapy
• Intervention / Treatment: Device: HYBENX®

Detailed Description

A new device (HYBENX®) has been developed with the purpose of destroying dental biofilm. The material contains a concentrated aqueous mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%).

The investigators planned a clinical and microbiological study using the decontaminant device in order to destroy the dental biofilm of root canals in cases of irreversible pulpitis. The ability of the decontaminant device to immediately stop bleeding during canal instrumentation was found out accidentally during the procedures of this still unpublished trial.

Due to this fact, the investigators were interested in evaluating the coagulation property of the material. Therefore, the aim of this prospective study is to describe a new approach to obtain hemostasis during root canal therapy using a sulfonic/sulfuric acid solution.

A total of 15 teeth with irreversible and acute pulpitis were included in the study. After manual and mechanical instrumentation of the root canal, a sterile paper point was introduced in the canal, and a first score was given based on the blood quantity.

The solution was used to irrigate the bleeding root canal; then a second sterile paper point was introduced, and the same score was assessed. The null hypothesis was that there is no difference in root canal bleeding before and after the use of the solution (⎧=0)

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• tooth affected by irreversible pulpitis, single-rooted teeth associated with healthy periodontium, physiologic sulcus depth (<3 mm), and absence of bleeding on probing of the involved teeth.

Exclusion Criteria:

• patients with systemic diseases using anticoagulants, antibiotics, or anti-inflammatory therapies in the last 30 days, patients with allergy to sulfur in any form, and pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HYBENX®; 1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Dr Riccardo Pace

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): January 10, 2017
• Study Completion (ACTUAL): January 17, 2017

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 16, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Disinfectants; Dental Disinfectants; Hybenx
• Other Study ID Numbers: endo1-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes