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

This study has been withdrawn prior to enrollment.
(Manufacturer changed device so no study will be done; ie it was never started)
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00806273
First received: December 8, 2008
Last updated: October 7, 2009
Last verified: October 2009
  Purpose

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.

Condition Intervention
Extirpation of the Tooth Pulp
Device: Vista Ultrasonic Bleach Bypass System
Device: Needle Irrigation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An in Vivo Comparison of the Debridement Efficacy of Needle Irrigation and Ultrasonic Root Canal Irrigation Techniques

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806273

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

No publications provided

Responsible Party: Ross Mitchell Co-Investigator, OHSU
ClinicalTrials.gov Identifier: NCT00806273     History of Changes
Other Study ID Numbers: IRB00004769
Study First Received: December 8, 2008
Last Updated: October 7, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
debridement
root canal

ClinicalTrials.gov processed this record on October 21, 2014