Tooth, NonvitalNCT02917642
Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals
A study testing Ultrasonic Irrigation and Non-Ultrasonic Irrigation in people with Tooth, Nonvital, run by University of Sao Paulo.
Trial summary
The purpose of this clinical study was to compare the effectiveness of passive ultrasonic irrigation with that of traditional syringe irrigation on the removal of bacteria and endotoxin (lipopolysaccharide [LPS]) from root canals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tooth, Nonvital
- What is being tested?
- Ultrasonic Irrigation and Non-Ultrasonic Irrigation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Teeth with necrotic pulps and asymptomatic apical periodontitis
Who cannot join
- patients who had received antibiotics during the previous 3 months or had any general disease,
- teeth that could not be properly isolated with rubber dam,
- non-restored teeth,
- periodontal pockets depths greater than 4 mm,
- previous endodontic treatment,
- open apex,
- crown/root fracture
- root resorption or calcifications.
About this study
Official title: Clinical Evaluation of the Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals
The purpose of this clinical study was to compare the effectiveness of passive ultrasonic irrigation with that of traditional syringe irrigation on the removal of bacteria and endotoxin (lipopolysaccharide [LPS]) from root canals.
Read the detailed description
Forty teeth with apical periodontitis were randomly allocated into two groups according to the irrigation protocol, passive ultrasonic irrigation (PUI, n = 20) and syringe and needle irrigation (NI, n = 20). Microbiological sampling was performed before (S1) and after the root canal preparation (S2), after the tested irrigation protocols (S3). Total bacteria counts were determined by a quantitative PCR (qPCR) assay; and the endotoxin levels by the LAL assay.
- Conditions
- Tooth, Nonvital
- Being tested
- Ultrasonic Irrigation, Non-Ultrasonic Irrigation
- Keywords
- bacterial infection, endotoxin, passive ultrasonic irrigation, root canal treatment
- Medical subject headings
- Tooth, Nonvital, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic IrrigationDevice
Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file
Non-Ultrasonic IrrigationDevice
Syringe and needle irrigation with no-ultrasonic activation
| Study group | Role | What they receive |
|---|---|---|
| Passive Ultrasonic Irrigation Protocol | Experimental | ultrasonic activation of antimicrobial solutions Receives: Device: Ultrasonic Irrigation |
| Non-Ultrasonic Irrigation Protocol | Active comparator | no-activation of antimicrobial solutions Receives: Device: Non-Ultrasonic Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Levels
Quantitative data of total bacterial counts determined by a DNA-based qPCR (quantitative polymerase chain reaction) assay
Measured: Through study completion, an average of 2 years
Secondary outcomes (1)
Endotoxin Levels
Quantitative data of endotoxin levels determined by the quantitative kinetic turbidimetric LAL assay
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startJan 2014
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tooth, NonvitalStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ericka Tavares Pinheiro, University of Sao Paulo
- Investigators
- Giulio Gavini, DDS, Ms, PhD, Study chair, Department of Dentistry, School of Dentistry, University of São Paulo.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917642
- Sponsor's protocol ID
- FAPESP2013/02923-9
- Status last verified
- Jul 2018
- First submitted
- 15 Sep 2016
- Last updated
- 3 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals
- ClinicalTrials.gov ID
- NCT02917642
- Acronym / sponsor ID
- FAPESP2013/02923-9
- Conditions
- Tooth, Nonvital
- Keywords
- bacterial infection, endotoxin, passive ultrasonic irrigation, root canal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Posted 3 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study was to compare the effectiveness of passive ultrasonic irrigation with that of traditional syringe irrigation on the removal of bacteria and endotoxin (lipopolysaccharide [LPS]) from root canals.
Detailed description
Forty teeth with apical periodontitis were randomly allocated into two groups according to the irrigation protocol, passive ultrasonic irrigation (PUI, n = 20) and syringe and needle irrigation (NI, n = 20). Microbiological sampling was performed before (S1) and after the root canal preparation (S2), after the tested irrigation protocols (S3). Total bacteria counts were determined by a quantitative PCR (qPCR) assay; and the endotoxin levels by the LAL assay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive Ultrasonic Irrigation Protocol | Experimental | Device: Ultrasonic Irrigationultrasonic activation of antimicrobial solutions |
| Non-Ultrasonic Irrigation Protocol | Active comparator | Device: Non-Ultrasonic Irrigationno-activation of antimicrobial solutions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Teeth with necrotic pulps and asymptomatic apical periodontitis
Key exclusion criteria (8 listed)
- patients who had received antibiotics during the previous 3 months or had any general disease,
- teeth that could not be properly isolated with rubber dam,
- non-restored teeth,
- periodontal pockets depths greater than 4 mm,
- previous endodontic treatment,
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 |
|---|---|---|
| Ultrasonic IrrigationPassive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file | Device | Passive Ultrasonic Irrigation Protocol |
| Non-Ultrasonic IrrigationSyringe and needle irrigation with no-ultrasonic activation | Device | Non-Ultrasonic Irrigation Protocol |
Primary outcome
Bacterial Levels
Time frame: Through study completion, an average of 2 years
Quantitative data of total bacterial counts determined by a DNA-based qPCR (quantitative polymerase chain reaction) assay
1 secondary outcome
Endotoxin Levels
Time frame: Through study completion, an average of 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Giulio Gavini, DDS, Ms, PhD study chair
Department of Dentistry, School of Dentistry, University of São Paulo.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic Irrigation and Non-Ultrasonic Irrigation in people with Tooth, Nonvital, run by University of Sao Paulo.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 3 Jul 2018. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bacterial Levels (time frame: Through study completion, an average of 2 years). 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 3 Jul 2018.