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A New Approach for Controlling Hemostasis During Canal Treatment

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ClinicalTrials.gov Identifier: NCT03336853
Recruitment Status : Completed
First Posted : November 8, 2017
Results First Posted : March 13, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Riccardo Pace, Azienda Ospedaliero-Universitaria Careggi

Tracking Information
First Submitted Date  ICMJE October 27, 2017
First Posted Date  ICMJE November 8, 2017
Results First Submitted Date  ICMJE January 18, 2019
Results First Posted Date  ICMJE March 13, 2019
Last Update Posted Date March 26, 2019
Actual Study Start Date  ICMJE April 1, 2017
Actual Primary Completion Date July 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
Change From Baseline in Root Canal Bleeding [ Time Frame: Baseline and After Treatment (20 seconds) ]
After the root canal, shaping was performed a first sterile paper point was introduced in the root canal, up to the working length, to detect blood presence. The millimeters of blood on the paper point were measured with a caliber. After the intervention (HybenX or placebo) a second sterile paper point was introduced in the root canal, up to the working length, to detect the presence of blood according the previous criteria
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
Change From Baseline in Root Canal Bleeding [ Time Frame: 20 sec ]
After the root canal, shaping was performed a first sterile paper point was introduced in the root canal, up to the working length, to detect blood presence. The millimeters of blood on the paper point were measured with a caliber. After the intervention (HybenX or placebo) a second sterile paper point was introduced in the root canal, up to the working length, to detect the presence of blood according the previous criteria
Change History Complete list of historical versions of study NCT03336853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A New Approach for Controlling Hemostasis During Canal Treatment
Official Title  ICMJE A New Approach for Controlling Hemostasis During Canal Treatment: a Randomized Controlled Study
Brief Summary

The persistence of blood may significantly affect final sealing with the persistence of microleakage (Zmener et al. 2008, Roggendorf et al. 2007).

In cases of copious bleeding from root canals, calcium hydroxide, anesthetic solution with 1:50,000 epinephrine or ferric sulfate placed on a sterile paper cone, are recognized as effective hemostatic agents (Magnusson 1971, Kouri et al. 1969, Dannenberg 1974).

The purpose of this study was to test the reduction of root canal bleeding in terms of significant percentage change for millimeters of blood in the canal at 2 different time points (baseline and after treatment with HybenX )

Detailed Description

A new device (HYBENX®, EPIEN Medical, Saint Paul, MN, USA) has been developed with the purpose of destroying dental biofilm. The material is a mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%).

This device has been successfully used in periodontology. Recent studies (Pini-Prato et al. 2016a, Isola et al. 2017) have demonstrated the effectiveness of the oral tissue decontaminant material in the treatment of clinical cases showing acute periodontal abscess without the use of systemic or local antibiotics. Similar favorable effects were obtained in the treatment of peri-implant mucositis and peri-implantitis (Pini-Prato et al. 2016b, Lopez et al. 2016). In addition, a randomized controlled trial (RCT) also demonstrated beneficial effects of the material in the treatment of oral aphthae (Porter et al. 2009).

Based on this scientific information, a clinical and microbiological study has been planned using the decontaminant device in cases of teeth with necrotic pulp with the aim to destroy the dental biofilm of root canals. 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 authors were interested in evaluating the coagulation property of the material. The purpose of this study was to test the reduction of root canal bleeding in terms of significant percentage change for millimeters of blood in the canal at 2 different time points (before and after treatment with HybenX ) A single center, participants and data analyst blind, two-arm, randomized, placebo controlled clinical trial study was performed following the CONSORT statement in the Endodontics Department, University Hospital Florence Careggi, Florence, Italy.

The study population consisted of patients that were treated by Endodontics Department of the University Hospital of Florence Careggi, Italy. Subject inclusion criteria were: patients aged between 20 and 60 years, able and willing to sign a consent form, single-rooted teeth with necrotic pulp confirmed by electric vitality test, associated with healthy periodontium, physiologic sulcus depth (<3 mm), and absence of bleeding on probing of the involved teeth.

Exclusion criteria were: 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. All subjects were informed of the nature and potential risks and benefits of their participation in the study. They also received information on the duration of the procedure, and the possible intraoperative and postoperative complications.

Treatment The root canal therapy procedure was standardized and limited to one experienced endodontist (R.P.). Treatments were performed at the Endodontics Departments of the University Hospital of Florence Careggi, Italy, under local anesthesia using 1.8 mL mepivacaine hydrochloride (Optocaine; Molteni Dental SRL, Scandicci, Italy), and the teeth were isolated with rubber dams. After preparing the access cavity, the working length was determined with an electronic apex locator (Propex II Dentsply Maillefer Instruments, Ballaigues, Switzerland) with a size 10 k-file. Root canals were shaped using ProTaper Universal NiTi files (Dentsply Maillefer Instruments, Ballaigues, Switzerland) in the following sequence: S1, S2, F1, F2, F3 until each instrument reached the working length. After each instrument, the root canals were rinsed with NaClO (Niclor 5, Ogna, Italy) using a syringe with a side-vented 30 G needle. ProTaper NiTi instruments were driven with an endodontic motor (XSmart Endo Motor, Dentsply Maillefer Instruments, Ballaigues, Switzerland) with a 16:1 contrangle set up as suggested by the manufacturer.

After the root canal, shaping was performed, and a first sterile paper point was introduced in the root canal, up to the working length, for 10 seconds to detect blood presence.

With a caliber, on the sterile paper cone, the millimeters of blood present within the root canal were measured.

Only the teeth that at this point showed 1 or more millimeters of blood within the root canal were included in the present study and randomized to the two experimental groups.

Before further treatment, the teeth were allocated to an experimental (HybenX) or a control group (sterile saline solution) according to an uneven block randomization designed by the statistician (A.N.). For each tooth, a closed envelope was opened in a consecutive order, assigning the tooth to either the experimental or the control group HybenX was approved as a Class I CE medical device by the Italian Ministry of Health (no. 483768) on February 7, 2012.

HybenX Group The material was introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement up to the working length.

Finally, the canal was rinsed with sterile water using a syringe with a side-vented 30 G needle 1 mm shorter than the working length.

A second sterile paper point was introduced in the root canal, up to the working length, for 10 seconds to detect the presence of blood and the millimeters of blood inside the root canal was measured again according the previous criteria.

Statistical Analysis Data were analyzed using SAS Version 9.3 software (SAS Institute, Inc., Cary, NC). A preliminary Levene's test was performed to verify the homogeneity of variance for the percentage change in the two groups.

Since the two groups showed homogeneity of the variance a t-test was performed to verify the null hypothesis by using a type I error equal to 0.05.

In order to confirm the firmness of the results a Wilcoxon non-parametric test was also carried out.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
single center, participants and data analyst blind, two-arm, randomized, placebo controlled clinical trial study
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Blood Contamination of Root Canal During Endodontic Therapy
Intervention  ICMJE
  • Device: HybenX

    The material was introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement up to the working length.

    Finally, the canal was rinsed with sterile water using a syringe with a side-vented 30 G needle 1 mm shorter than the working length.

    A second sterile paper point was introduced in the root canal, up to the working length, for 10 seconds to detect the presence of blood and the millimeters of blood inside the root canal was measured again according the previous criteria.

  • Other: Placebo control

    The root canal was irrigated with sterile saline water with a syringe and a side-vented 30G needle activated for 20 seconds with a sterile paper point with and up and down movement up to the working length to ensure a flow of irrigant solution throughout the canal.

    Finally, the canal was rinsed with sterile water using a syringe with a side-vented 30 G needle 1 mm shorter than the working length. A second sterile paper point was introduced in the root canal, up to the working length, for 10 seconds to detect the presence of blood and the millimeters of blood inside the root canal was measured again according the previous criteria.

Study Arms  ICMJE
  • Experimental: HybenX ®
    1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec
    Intervention: Device: HybenX
  • Placebo Comparator: Control
    5 cc of sterile saline water for 20 sec
    Intervention: Other: Placebo control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2018)
60
Original Actual Enrollment  ICMJE
 (submitted: November 6, 2017)
26
Actual Study Completion Date  ICMJE December 22, 2017
Actual Primary Completion Date July 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients aged between 20 and 60 years
  • patients able and willing to sign a consent form,
  • single-rooted teeth with necrotic pulp confirmed by electric vitality test
  • healthy periodontium
  • physiologic sulcus depth (<3 mm)
  • absence of bleeding on probing of the involved teeth.

Exclusion Criteria:

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

All subjects were informed of the nature and potential risks and benefits of their participation in the study

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03336853
Other Study ID Numbers  ICMJE endo 2-2017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr Riccardo Pace, Azienda Ospedaliero-Universitaria Careggi
Study Sponsor  ICMJE Dr Riccardo Pace
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Azienda Ospedaliero-Universitaria Careggi
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP