Effect of Apical Negative Pressure Irrigation System at Cleaning Lateral Canals and Reduction of Periapical Lesions After Endodontic Therapy

The aim of the present study is to assess with PA x-rays and CBCT scans the volumetric changes in periapical radiolucencies in endodontically treated teeth 1 year after endodontic treatment and evaluate how well the lateral canals are filled after irrigation with the new generation of negative irrigation pressure unit with and without the ultrasonic irrigation.

Study Overview

• Status: Unknown
• Conditions: Root Canal Infection
• Intervention / Treatment: Device: Irrigation Technique 1; Device: Irrigation Technique 2

Detailed Description

This is a single center, prospective clinical study conducted in patients who present for routine endodontic therapy. The study has been reviewed and approved by the Institutional Review Board (Ethics Committee) Aspire IRB located at Santee, CA. The clinical investigator will treat patients who present with radiographic evidence of periapical pathology and will randomize the subjects to either negative pressure irrigation system treatment (EndoVac Pure) with ultrasonic irrigation or negative pressure irrigation system treatment (Endovac Pure) without ultrasonic irrigation. All other aspects of the treatment (access, instrumentation and obturation will be according to clinicians conventional clinical judgment. Subjects will have a pre-treatment PA x-ray and CBCT scan before treatment, a PA x-ray at six months and a CBCT scan at one year post-treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Niles, Illinois, United States, 60714
      • Recruiting
      • King Endodontics,LLC
      • Contact: Maria Javier, MD; Phone Number: 714-516-7680; Email: Mara.Javier@ykavokerr.com
      • Principal Investigator: Brett Gilbert, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
• Aged at least 18 years.
• Understands and is willing, able and likely to comply with all study procedures and restrictions.
• Good general and mental health in the opinion of the investigator or medically qualified designee;
• No clinically significant and relevant abnormalities of medical history or oral examination;
• Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
• Single or multi rooted-canal teeth diagnosed with pulp necrosis and symptomatic/ asymptomatic apical periodontitis as tested with routine diagnostics.
• Radiographic evidence of periapical lesion.

Exclusion Criteria:

• Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
• Women who are breast-feeding.
• Pre-existing oral irritations. b) Recent (within 30 days) gingival/oral surgery. c) Any clinically significant or relevant oral abnormality.
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Any subject requiring re-treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Irrigation Technique 1; Patients randomized into this group will be treated using EndoVac Pure followed by Ultrasonic Irrigation.	Device: Irrigation Technique 1; Irrigation of root canals for this group will be performed using EndoVac Pure, an Apical Negative Pressure Endodontic Irrigation System intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures. The Endovac Pure is a negative pressure system that utilizes negative pressure irrigation so irrigants are suctioned apically from the pulp chamber to the apical terminus and then through the dental office High Volume Evacuation (HVE) valve (Hi-VAC) system. Endovac Pure is designed to be used with Sodium Hypochlorite (NaOCl or bleach) and EDTA (Ethylenediaminetetraacetic acid). This will be followed by Ultrasonic activation of the sodium hypochlorite solution using Minendo II ultrasonic unit.
Experimental: Irrigation Technique 2; Patients randomized into this group will be treated using EndoVac Pure only.	Device: Irrigation Technique 2; Irrigation of root canals for this group will be performed using the EndoVac pure system without Ultrasonic irrigation. The Endovac Pure is a negative pressure system that utilizes negative pressure irrigation so irrigants are suctioned apically from the pulp chamber to the apical terminus and then through the dental office High Volume Evacuation (HVE) valve (Hi-VAC) system. Endovac Pure is designed to be used with Sodium Hypochlorite (NaOCl or bleach) and EDTA (Ethylenediaminetetraacetic acid).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline - Size of the lesion in the lateral canals at 1 year	Evaluate the efficacy of EndoVac Pure at cleaning lateral canals as evidenced by post-treatment CBCT scans. CBCT images will be analyzed and the size of the lesion will be measured and will be evaluated.	1 year after endodontic therapy
Change from baseline - Length of lateral canal filled at 6 months and 1 year	The study will also evaluate how well the lateral canals are filled after irrigation with the new generation of negative irrigation pressure unit with and without the ultrasonic irrigation The amount of filling material visualized in each lateral canal will be calculated and expressed as a percentage of linear extension (length of the lateral canal that was filled, in relation to its entire length in mm).	6 months and 1 year post treatment
Change from baseline - Area of the lateral canal filled at 6 months and 1 year	The study will also measure the area occupied by the filling material inside the lateral canal in relation to its entire area in mm²).	6 months and 1 year post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline - Periapical radiographic healing	Compare the outcome of periapical radiographic healing 6 months and 1 year after endodontic treatment The Periapical Radiographs will be analyzed and the size of the lesion will be measured in two dimensions: mesio-distal and coronal-apical. The lesion will be evaluated based on the findings below: Evaluation of Radiographic Findings: Normal periapical structures; Small changes in bone structures (PAI ≤2); Changes in bone structures (PAI ≥3); Periodontitis with well- defined radiolucent area; Severe periodontitis	6 months and 1 year after endodontic therapy

Collaborators and Investigators

• Sponsor: KaVo Kerr
• Investigators: Principal Investigator: Brett Gilbert, DDS, King Endodontics, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 27, 2017

Study Record Updates

• Last Update Posted (Actual): December 27, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Root Canal Treatment
• Other Study ID Numbers: KK-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes