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

NCT03384004 | Unknown FDA Device

• 1 other identifier: KK-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Root Canal Treatment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change from baseline - Periapical radiographic healing

  6 months and 1 year after endodontic therapy

Study Arms (2)

Irrigation Technique 1

EXPERIMENTAL

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

Device: Irrigation Technique 1

Irrigation Technique 2

EXPERIMENTAL

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

Device: Irrigation Technique 2

Interventions

Irrigation Technique 1 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 1

Irrigation Technique 2 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).

Irrigation Technique 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KaVo Kerr: lead

Study Sites (1)

King Endodontics,LLC

Niles, Illinois, 60714, United States

RECRUITING

Study Officials

• Brett Gilbert, DDS

  King Endodontics, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Javier, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 27, 2017
• Study Start: November 20, 2017
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: December 27, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)