N/A
N=60
A New Approach for Controlling Hemostasis During Canal Treatment
Blood Contamination of Root Canal During Endodontic Therapy
Bottom Line
View on ClinicalTrials.gov: NCT03336853 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Change From Baseline in Root Canal Bleeding — 3.40; 3.73; 0.26; 3.03 millimeters — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HybenX (Device); Placebo control (Other)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Dr Riccardo Pace
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Root Canal Bleeding |
3.40; 3.73; 0.26; 3.03 | <.0001 sig |
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 )
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03336853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.