Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-02 @ 6:49 AM
Study NCT ID:
NCT03384004
Status:
UNKNOWN
Last Update Posted:
2017-12-27
First Post:
2017-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Apical Negative Pressure Irrigation System at Cleaning Lateral Canals and Reduction of Periapical Lesions After Endodontic Therapy
Sponsor:
KaVo Kerr
Organization:
Study Overview
Official Title:
Effect of Apical Negative Pressure Irrigation System at Cleaning Lateral Canals and Reduction of Periapical Lesions After Endodontic Therapy
Status:
UNKNOWN
Status Verified Date:
2017-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: