A New Approach for Controlling Hemostasis During Canal Treatment

NCT03336853 | Completed Results FDA Device

• 1 other identifier: endo 2-2017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 )

Conditions

Blood Contamination of Root Canal During Endodontic Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Root Canal Bleeding

  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

  Baseline and After Treatment (20 seconds)

Study Arms (2)

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

Control

PLACEBO COMPARATOR

5 cc of sterile saline water for 20 sec

Other: Placebo control

Interventions

HybenX DEVICE

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.

HybenX ®

Placebo control OTHER

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.

Control

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Riccardo Pace: lead

Study Sites (1)

AOUCareggi

Florence, 50100, Italy

Location

Related Publications (10)

• Pini-Prato G, Magnani C, Rotundo R. Nonsurgical Treatment of Peri-implantitis Using the Biofilm Decontamination Approach: A Case Report Study. Int J Periodontics Restorative Dent. 2016 May-Jun;36(3):383-91. doi: 10.11607/prd.2653.

  PMID: 27100808 BACKGROUND

• Lopez MA, Andreasi Bassi M, Confalone L, Silvestre F, Arcuri C. The treatment of peri-implant diseases: a new approach using hybenx(R) as a decontaminant for implant surface and oral tissues. Oral Implantol (Rome). 2016 Nov 13;9(3):106-114. doi: 10.11138/orl/2016.9.3.106. eCollection 2016 Jul-Sep.

  PMID: 28042438 BACKGROUND

• Porter SR, Al-Johani K, Fedele S, Moles DR. Randomised controlled trial of the efficacy of HybenX in the symptomatic treatment of recurrent aphthous stomatitis. Oral Dis. 2009 Mar;15(2):155-61. doi: 10.1111/j.1601-0825.2008.01503.x.

  PMID: 19207485 BACKGROUND

• Zmener O, Pameijer CH, Serrano SA, Vidueira M, Macchi RL. Significance of moist root canal dentin with the use of methacrylate-based endodontic sealers: an in vitro coronal dye leakage study. J Endod. 2008 Jan;34(1):76-9. doi: 10.1016/j.joen.2007.10.012.

  PMID: 18155498 BACKGROUND

• Roggendorf MJ, Ebert J, Petschelt A, Frankenberger R. Influence of moisture on the apical seal of root canal fillings with five different types of sealer. J Endod. 2007 Jan;33(1):31-3. doi: 10.1016/j.joen.2006.07.006. Epub 2006 Oct 13.

  PMID: 17185125 BACKGROUND

• Magnusson B. Therapeutic pulpotomy in primary molars--clinical and histological follow-up. II. Zinc oxide-eugenol as wound dressing. Odontol Revy. 1971;22(1):45-54. No abstract available.

  PMID: 5280515 BACKGROUND

• Kouri EM, Matthews JL, Taylor PP. Epinephrine in pulpotomy. ASDC J Dent Child. 1969 Mar-Apr;36(2):123-8. No abstract available.

  PMID: 4888301 BACKGROUND

• Dannenberg JL. Pedodontic endodontics. Dent Clin North Am. 1974 Apr;18(2):367-77. No abstract available.

  PMID: 4274315 BACKGROUND

• Isola G, Matarese G, Williams RC, Siciliano VI, Alibrandi A, Cordasco G, Ramaglia L. The effects of a desiccant agent in the treatment of chronic periodontitis: a randomized, controlled clinical trial. Clin Oral Investig. 2018 Mar;22(2):791-800. doi: 10.1007/s00784-017-2154-7. Epub 2017 Jun 17.

  PMID: 28624914 BACKGROUND

• Pini-Prato G, Magnani C, Rotundo R. Treatment of Acute Periodontal Abscesses Using the Biofilm Decontamination Approach: A Case Report Study. Int J Periodontics Restorative Dent. 2016 Jan-Feb;36(1):55-63. doi: 10.11607/prd.2557.

  PMID: 26697553 BACKGROUND

Results Point of Contact

• Title: Dr. Riccardo Pace
• Organization: AOUCareggi

riccardo.pace@unifi.it

+390557945608

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single center, participants and data analyst blind, two-arm, randomized, placebo controlled clinical trial study

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 8, 2017
• Study Start: April 1, 2017
• Primary Completion: July 21, 2017
• Study Completion: December 22, 2017
• Last Updated: March 26, 2019
• Results First Posted: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)