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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00806273
Recruitment Status : Withdrawn (Manufacturer changed device so no study will be done; ie it was never started)
First Posted : December 10, 2008
Last Update Posted : October 8, 2009
Information provided by:
Oregon Health and Science University

Brief 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. 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
  5. 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.

Condition or disease Intervention/treatment Phase
Extirpation of the Tooth Pulp Device: Vista Ultrasonic Bleach Bypass System Device: Needle Irrigation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An in Vivo Comparison of the Debridement Efficacy of Needle Irrigation and Ultrasonic Root Canal Irrigation Techniques
Study Start Date : January 2009
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : November 2009

Arm Intervention/treatment
Active Comparator: Group 2
For Group II, the ultrasonic irrigation system involves using an initial irrigation with a conventional syringe followed by ultrasonic irrigation.
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.
Active Comparator: Group 1
For Group I, needle irrigation will be delivered into the pulp chamber using a syringe tip placed above the access opening and removed with high volume suction.
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.

Primary Outcome Measures :
  1. Software program to quantify the amount of debris left in the canals. Debris was reported as percent of canal space [ Time Frame: 7-10 days post extraction ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • ASA 1
  • ASA 2
  • Pts have current treatment plan at OHSU for extraction of some or all of remaining teeth and scheduled for delivery of a removable appliance post extraction
  • Teeth used are able to be isolated with rubber dam
  • Understand and sign consent form

Exclusion Criteria:

  • ASA 3+
  • No current treatment plan at OHSU
  • Severely carious teeth resulting in inability to isolate for procedure
  • Unable to understand or sign consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00806273

Sponsors and Collaborators
Oregon Health and Science University
Principal Investigator: Craig Baumgartner, DDS, PhD Oregon Health & Science University: Grad Endodontology

Responsible Party: Ross Mitchell Co-Investigator, OHSU Identifier: NCT00806273     History of Changes
Other Study ID Numbers: IRB00004769
First Posted: December 10, 2008    Key Record Dates
Last Update Posted: October 8, 2009
Last Verified: October 2009

Keywords provided by Oregon Health and Science University:
root canal