An in Vivo Comparison of the Debridement Efficiency of Needle Irrigation Versus Ultrasonic Irrigation

Summary

Study/Protocol Title: An in vivo comparison of the debridement efficacy of needle irrigation and ultrasonic root canal irrigation techniques

1. The purpose of this study is to compare the Vista ultrasonic bypass system and conventional needle irrigation to effectively clean the bottom third of the root canal during root canal therapy.
2. Participants will be recruited from the general patient pool of the OHSU School of Dentistry. Patients will have to qualify for the study by meeting the following criteria: age between 18 and 75 years old, ASA status I or II, are currently planning treatment for the extraction of teeth, and the patient understands and signs the consent form. The principal investigator will conduct an interview with the patient and the student-provider, and obtain informed consent from the patient.
3. The teeth to be extracted will be numbed with local anesthetic. The teeth will be isolated with a rubber dam and disinfected. The pulp chamber will be accessed using normal dental equipment and the root canal will be cleaned and shaped using either the ultrasonic irrigation technique or needle irrigation. This is the first step of standard root canal therapy. The tooth will then be extracted and the principal investigator will retain extracted teeth to perform further examination to see how thoroughly the root canals were cleaned. The teeth will be discarded after study.
4. Not applicable
5. The investigational device (Vista ultrasonic bypass system) consists of a 30 gauge slot needle which attaches to an ultrasonic unit (Satalec P5). Irrigants will be delivered to the apical 1/3 of the root canal through the needle at the same time the needle is being activated ultrasonically. Irrigant delivery will be controlled by a standard syringe pump. Conventional needle irrigation will be delivered using a 27guage slot needle placed into the root canal. Irrigants will be expressed with positive pressure at a location in the canal short of the needle binding
6. Once the first step of root canal therapy has been completed, the tooth will be extracted, decalcified, and tissue specimens will be taken from the bottom 3 mm. These sections will be evaluated under magnification and remaining debris in the root canal will be quantified using the NIH Image software. The data will be statistically analyzed to determine and differences between the two irrigation techniques.

Conditions

• Extirpation of the Tooth Pulp

Interventions

DEVICE

Vista Ultrasonic Bleach Bypass System

The ultrasonic needle will be activated by depressing the foot pedal which will begin the debridement process. Irrigants will be delivered constantly at the recommended rate via the syringe pump and the needle tip will be moved up and down with a 2mm amplitude for the entire 1 minute activation cycle, which will deliver a total of 3ml of irrigant. The ultrasonic unit will be turned off and the needle will be withdrawn from the canal.

DEVICE

Needle Irrigation

irrigation with 3ml 6% NaOCl is performed moving the needle from just short of binding to 2mm coronal in constant motion for 60 seconds and left untouched in a full canal for 60 seconds.

Sponsors & Collaborators

• Oregon Health and Science University

  lead OTHER

Principal Investigators

• Craig Baumgartner, DDS, PhD · Oregon Health & Science University: Grad Endodontology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-01-31

Primary Completion

2009-11-30

Completion

2009-11-30