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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

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 )


Condition or disease Intervention/treatment Phase
Blood Contamination of Root Canal During Endodontic Therapy Device: HybenX Other: Placebo control Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Official Title: A New Approach for Controlling Hemostasis During Canal Treatment: a Randomized Controlled Study
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : July 21, 2017
Actual Study Completion Date : December 22, 2017

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 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.


Placebo Comparator: Control
5 cc of sterile saline water for 20 sec
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.





Primary Outcome Measures :
  1. 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




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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336853


Locations
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Italy
AOUCareggi
Firenze, Italy, 50100
Sponsors and Collaborators
Dr Riccardo Pace
  Study Documents (Full-Text)

Documents provided by Dr Riccardo Pace, Azienda Ospedaliero-Universitaria Careggi:

Publications:

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Responsible Party: Dr Riccardo Pace, Principal Investigator, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT03336853     History of Changes
Other Study ID Numbers: endo 2-2017
First Posted: November 8, 2017    Key Record Dates
Results First Posted: March 13, 2019
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Hemostatics
Coagulants