Recruiting

Apical Negative Pressure

Sponsor:

KaVo Kerr

Code:

NCT03384004

Conditions

Root Canal Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Irrigation Technique 1

Irrigation Technique 2

Study Details

Brief summary:

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.

Conditions

Root Canal Infection

Study ID

NCT03384004

Start date

Nov 20, 2017

Status verified date

Dec, 2017

Completion date

Jan, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Irrigation Technique 1

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

experimental: Irrigation Technique 2

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

Interventions

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.

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).

Primary outcome measure

  • Change from baseline - Size of the lesion in the lateral canals at 1 year [ Time Frame: 1 year after endodontic therapy ]
  • Change from baseline - Length of lateral canal filled at 6 months and 1 year [ Time Frame: 6 months and 1 year post treatment ]
  • Change from baseline - Area of the lateral canal filled at 6 months and 1 year [ Time Frame: 6 months and 1 year post treatment ]

Central Contacts and Locations

Central contacts

Maria Javier, MD

(714)-516-7680Maria.Javier@kavokerr.com

Locations

King Endodontics,LLC

Recruiting

Niles, Illinois, United States, 60714

Contacts

Maria Javier, MD

714-516-7680Mara.Javier@ykavokerr.com

Principal Investigator:

Brett Gilbert, DDS

More Information

Sponsor

KaVo Kerr

Last update posted

Dec 27, 2017

Last verified

Dec, 2017

Keywords

  • Root Canal Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by KaVo Kerr on 2017-12-27.