Extirpation of the Tooth PulpNCT00806273
An in Vivo Comparison of the Debridement Efficiency of Needle Irrigation Versus Ultrasonic Irrigation
A study testing Vista Ultrasonic Bleach Bypass System and Needle Irrigation in people with Extirpation of the Tooth Pulp, run by Oregon Health and Science University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Extirpation of the Tooth Pulp
- What is being tested?
- Vista Ultrasonic Bleach Bypass System and Needle Irrigation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: An in Vivo Comparison of the Debridement Efficacy of Needle Irrigation and Ultrasonic Root Canal Irrigation Techniques
Study/Protocol Title: An in vivo comparison of the debridement efficacy of needle irrigation and ultrasonic root canal irrigation techniques
- 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.
- 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.
- 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.
- Not applicable
- 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
- 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
- Being tested
- Vista Ultrasonic Bleach Bypass System, Needle Irrigation
- Keywords
- debridement, root canal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vista Ultrasonic Bleach Bypass SystemDevice
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.
Needle IrrigationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Active comparator | For Group II, the ultrasonic irrigation system involves using an initial irrigation with a conventional syringe followed by ultrasonic irrigation. Receives: Device: Vista Ultrasonic Bleach Bypass System |
| Group 1 | Active comparator | 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. Receives: Device: Needle Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Software program to quantify the amount of debris left in the canals. Debris was reported as percent of canal space
Measured: 7-10 days post extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionNov 2009 (estimated)
- Study completionNov 2009 (estimated)
Why it stopped: Manufacturer changed device so no study will be done; ie it was never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extirpation of the Tooth PulpStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Craig Baumgartner, DDS, PhD, Principal investigator, Oregon Health & Science University: Grad Endodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806273
- Sponsor's protocol ID
- IRB00004769
- Status last verified
- Jun 2019
- First submitted
- 8 Dec 2008
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An in Vivo Comparison of the Debridement Efficacy of Needle Irrigation and Ultrasonic Root Canal Irrigation Techniques
- ClinicalTrials.gov ID
- NCT00806273
- Acronym / sponsor ID
- IRB00004769
- Conditions
- Extirpation of the Tooth Pulp
- Keywords
- debridement, root canal
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Manufacturer changed device so no study will be done; ie it was never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 10 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study/Protocol Title: An in vivo comparison of the debridement efficacy of needle irrigation and ultrasonic root canal irrigation techniques
- 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.
- 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.
- 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.
- Not applicable
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Active comparator | Device: Vista Ultrasonic Bleach Bypass SystemFor Group II, the ultrasonic irrigation system involves using an initial irrigation with a conventional syringe followed by ultrasonic irrigation. |
| Group 1 | Active comparator | Device: Needle IrrigationFor 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vista Ultrasonic Bleach Bypass SystemThe 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 | Group 2 |
| Needle Irrigationirrigation 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. | Device | Group 1 |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Baumgartner, DDS, PhD principal investigator
Oregon Health & Science University: Grad Endodontology
Questions about this trial
What is this clinical trial studying?
A study testing Vista Ultrasonic Bleach Bypass System and Needle Irrigation in people with Extirpation of the Tooth Pulp, run by Oregon Health and Science University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.