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

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.

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.