MedDataX Logo

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

NCT ID: NCT03384004

Last Updated: 2017-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-20

Study Completion Date

2019-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Root Canal Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Root Canal Treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Irrigation Technique 1

Patients randomized into this group will be treated using EndoVac Pure followed by Ultrasonic Irrigation.

Group Type EXPERIMENTAL

Irrigation Technique 1

Intervention Type DEVICE

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.

Irrigation Technique 2

Patients randomized into this group will be treated using EndoVac Pure only.

Group Type EXPERIMENTAL

Irrigation Technique 2

Intervention Type DEVICE

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

KaVo Kerr

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Brett Gilbert, DDS

Role: PRINCIPAL_INVESTIGATOR

King Endodontics, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

King Endodontics,LLC

Niles, Illinois, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Maria Javier, MD

Role: CONTACT

Phone: (714)-516-7680

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Maria Javier, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KK-002

Identifier Type: -

Identifier Source: org_study_id