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

NCT03060486 | Completed Results FDA Device

• 1 other identifier: endo1-2016
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Blood Contamination of Root Canal During Endodontic Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

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.

HYBENX®

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Riccardo Pace: lead

Results Point of Contact

• Title: Riccardo Pace, DMD
• Organization: AOU Careggi

riccardo.pace@unifi.it

00390557945608

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 23, 2017
• Study Start: December 1, 2016
• Primary Completion: January 10, 2017
• Study Completion: January 17, 2017
• Last Updated: October 17, 2018
• Results First Posted: October 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share