A New Approach for Controlling Hemostasis During Canal Treatment: a Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Root Canal Bleeding
Study Overview
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immediately stop bleeding during canal instrumentation was found out accidentally during the procedures of this still unpublished trial.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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
HybenX ®
1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec
Intervention: HybenX (Device)
Control
5 cc of sterile saline water for 20 sec
Intervention: Placebo control (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Riccardo Pace
Principal Investigator
Azienda Ospedaliero-Universitaria Careggi