Clinical trial NCT03384004: Effect of Apical Negative Pressure Irrigation System at Cleaning Lateral Canals and Reduction of Periapical Lesions After Endodontic Therapy
Official title: Effect of Apical Negative Pressure Irrigation System at Cleaning Lateral Canals and Reduction of Periapical Lesions After Endodontic Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Root Canal Infection
Keywords: Root Canal Treatment
Lead sponsor: KaVo Kerr
Sponsor class: INDUSTRY
First posted: 2017-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline - Size of the lesion in the lateral canals at 1 year
timeFrame: 1 year after endodontic therapy
measure: Change from baseline - Length of lateral canal filled at 6 months and 1 year
timeFrame: 6 months and 1 year post treatment
measure: Change from baseline - Area of the lateral canal filled at 6 months and 1 year
timeFrame: 6 months and 1 year post treatment
Secondary outcomes:
measure: Change from baseline - Periapical radiographic healing
timeFrame: 6 months and 1 year after endodontic therapy
Other outcomes:
Locations:
city: Niles
country: United States
facility: King Endodontics,LLC
state: Illinois
Study officials:
affiliation: King Endodontics, LLC
name: Brett Gilbert, DDS
role: PRINCIPAL_INVESTIGATOR
References: