Root Canal InfectionNCT03384004
Effect of Apical Negative Pressure Irrigation System at Cleaning Lateral Canals and Reduction of Periapical Lesions After Endodontic Therapy
A study testing Irrigation Technique 1 and Irrigation Technique 2 in people with Root Canal Infection, run by KaVo Kerr at 1 site in United States.
Trial summary
The aim of the present study is to assess with PA x-rays and CBCT scans the volumetric changes in periapical radiolucencies in endodontically treated teeth 1 year after endodontic treatment and evaluate how well the lateral canals are filled after irrigation with the new generation of negative irrigation pressure unit… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Root Canal Infection
- What is being tested?
- Irrigation Technique 1 and Irrigation Technique 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2017to Jan 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Aged at least 18 years.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Good general and mental health in the opinion of the investigator or medically qualified designee;
- No clinically significant and relevant abnormalities of medical history or oral examination;
- Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
- Single or multi rooted-canal teeth diagnosed with pulp necrosis and symptomatic/ asymptomatic apical periodontitis as tested with routine diagnostics.
- Radiographic evidence of periapical lesion.
Who cannot join
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are breast-feeding.
- Pre-existing oral irritations. b) Recent (within 30 days) gingival/oral surgery. c) Any clinically significant or relevant oral abnormality.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Any subject requiring re-treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
King Endodontics,LLC
Niles, Illinois, 60714
Maria Javier, MD, 714-516-7680, Mara.Javier@ykavokerr.com
Brett Gilbert, DDS
About this study
The aim of the present study is to assess with PA x-rays and CBCT scans the volumetric changes in periapical radiolucencies in endodontically treated teeth 1 year after endodontic treatment and evaluate how well the lateral canals are filled after irrigation with the new generation of negative irrigation pressure unit with and without the ultrasonic irrigation.
Read the detailed description
This is a single center, prospective clinical study conducted in patients who present for routine endodontic therapy. The study has been reviewed and approved by the Institutional Review Board (Ethics Committee) Aspire IRB located at Santee, CA. The clinical investigator will treat patients who present with radiographic evidence of periapical pathology and will randomize the subjects to either negative pressure irrigation system treatment (EndoVac Pure) with ultrasonic irrigation or negative pressure irrigation system treatment (Endovac Pure) without ultrasonic irrigation. All other aspects of the treatment (access, instrumentation and obturation will be according to clinicians conventional clinical judgment. Subjects will have a pre-treatment PA x-ray and CBCT scan before treatment, a PA x-ray at six months and a CBCT scan at one year post-treatment.
- Conditions
- Root Canal Infection
- Being tested
- Irrigation Technique 1, Irrigation Technique 2
- Keywords
- Root Canal Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigation Technique 1Device
Irrigation of root canals for this group will be performed using EndoVac Pure, an Apical Negative Pressure Endodontic Irrigation System intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures. The Endovac Pure is a negative pressure system that utilizes negative pressure irrigation so irrigants are suctioned apically from the pulp chamber to the apical terminus and then through the dental office High Volume Evacuation (HVE) valve (Hi-VAC) system. Endovac Pure is designed to be used with Sodium Hypochlorite (NaOCl or bleach) and EDTA (Ethylenediaminetetraacetic acid). This will be followed by Ultrasonic activation of the sodium hypochlorite solution using Minendo II ultrasonic unit.
Irrigation Technique 2Device
Irrigation of root canals for this group will be performed using the EndoVac pure system without Ultrasonic irrigation. The Endovac Pure is a negative pressure system that utilizes negative pressure irrigation so irrigants are suctioned apically from the pulp chamber to the apical terminus and then through the dental office High Volume Evacuation (HVE) valve (Hi-VAC) system. Endovac Pure is designed to be used with Sodium Hypochlorite (NaOCl or bleach) and EDTA (Ethylenediaminetetraacetic acid).
| Study group | Role | What they receive |
|---|---|---|
| Irrigation Technique 1 | Experimental | Patients randomized into this group will be treated using EndoVac Pure followed by Ultrasonic Irrigation. Receives: Device: Irrigation Technique 1 |
| Irrigation Technique 2 | Experimental | Patients randomized into this group will be treated using EndoVac Pure only. Receives: Device: Irrigation Technique 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline - Size of the lesion in the lateral canals at 1 year
Evaluate the efficacy of EndoVac Pure at cleaning lateral canals as evidenced by post-treatment CBCT scans.
CBCT images will be analyzed and the size of the lesion will be measured and will be evaluated.
Measured: 1 year after endodontic therapy
Change from baseline - Length of lateral canal filled at 6 months and 1 year
The study will also evaluate how well the lateral canals are filled after irrigation with the new generation of negative irrigation pressure unit with and without the ultrasonic irrigation The amount of filling material visualized in each lateral canal will be calculated and expressed as a percentage of linear extension (length of the lateral canal that was filled, in relation to its entire length in mm).
Measured: 6 months and 1 year post treatment
Change from baseline - Area of the lateral canal filled at 6 months and 1 year
The study will also measure the area occupied by the filling material inside the lateral canal in relation to its entire area in mm²).
Measured: 6 months and 1 year post treatment
Secondary outcomes (1)
Change from baseline - Periapical radiographic healing
Compare the outcome of periapical radiographic healing 6 months and 1 year after endodontic treatment
The Periapical Radiographs will be analyzed and the size of the lesion will be measured in two dimensions: mesio-distal and coronal-apical. The lesion will be evaluated based on the findings below:
Evaluation of Radiographic Findings:
- Normal periapical structures
- Small changes in bone structures (PAI ≤2)
- Changes in bone structures (PAI ≥3)
- Periodontitis with well- defined radiolucent area
- Severe periodontitis
Measured: 6 months and 1 year after endodontic therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start20 Nov 2017
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal InfectionStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KaVo Kerr
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brett Gilbert, DDS, Principal investigator, King Endodontics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384004
- Sponsor's protocol ID
- KK-002
- Status last verified
- Dec 2017
- First submitted
- 14 Dec 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Apical Negative Pressure Irrigation System at Cleaning Lateral Canals and Reduction of Periapical Lesions After Endodontic Therapy
- ClinicalTrials.gov ID
- NCT03384004
- Acronym / sponsor ID
- KK-002
- Conditions
- Root Canal Infection
- Keywords
- Root Canal Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- KaVo KerrIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 27 Dec 2017 (actual)
- 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.
The aim of the present study is to assess with PA x-rays and CBCT scans the volumetric changes in periapical radiolucencies in endodontically treated teeth 1 year after endodontic treatment and evaluate how well the lateral canals are filled after irrigation with the new generation of negative irrigation pressure unit with and without the ultrasonic irrigation.
Detailed description
This is a single center, prospective clinical study conducted in patients who present for routine endodontic therapy. The study has been reviewed and approved by the Institutional Review Board (Ethics Committee) Aspire IRB located at Santee, CA. The clinical investigator will treat patients who present with radiographic evidence of periapical pathology and will randomize the subjects to either negative pressure irrigation system treatment (EndoVac Pure) with ultrasonic irrigation or negative pressure irrigation system treatment (Endovac Pure) without ultrasonic irrigation. All other aspects of the treatment (access, instrumentation and obturation will be according to clinicians conventional clinical judgment. Subjects will have a pre-treatment PA x-ray and CBCT scan before treatment, a PA x-ray at six months and a CBCT scan at one year post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irrigation Technique 1 | Experimental | Device: Irrigation Technique 1Patients randomized into this group will be treated using EndoVac Pure followed by Ultrasonic Irrigation. |
| Irrigation Technique 2 | Experimental | Device: Irrigation Technique 2Patients randomized into this group will be treated using EndoVac Pure only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Aged at least 18 years.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Good general and mental health in the opinion of the investigator or medically qualified designee;
- No clinically significant and relevant abnormalities of medical history or oral examination;
Key exclusion criteria (5 listed)
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are breast-feeding.
- Pre-existing oral irritations. b) Recent (within 30 days) gingival/oral surgery. c) Any clinically significant or relevant oral abnormality.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Any subject requiring re-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 |
|---|---|---|
| Irrigation Technique 1Irrigation of root canals for this group will be performed using EndoVac Pure, an Apical Negative Pressure Endodontic Irrigation System intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures. The Endovac Pure is a negative pressure system that utilizes negative pressure irrigation so irrigants are suctioned apically from the pulp chamber to the apical terminus and then through the dental office High Volume Evacuation (HVE) valve (Hi-VAC) system. Endovac Pure is designed to be used with Sodium Hypochlorite (NaOCl or bleach) and EDTA (Ethylenediaminetetraacetic acid). This will be followed by Ultrasonic activation of the sodium hypochlorite solution using Minendo II ultrasonic unit. | Device | Irrigation Technique 1 |
| Irrigation Technique 2Irrigation of root canals for this group will be performed using the EndoVac pure system without Ultrasonic irrigation. The Endovac Pure is a negative pressure system that utilizes negative pressure irrigation so irrigants are suctioned apically from the pulp chamber to the apical terminus and then through the dental office High Volume Evacuation (HVE) valve (Hi-VAC) system. Endovac Pure is designed to be used with Sodium Hypochlorite (NaOCl or bleach) and EDTA (Ethylenediaminetetraacetic acid). | Device | Irrigation Technique 2 |
Primary outcome
Change from baseline - Size of the lesion in the lateral canals at 1 year
Time frame: 1 year after endodontic therapy
Evaluate the efficacy of EndoVac Pure at cleaning lateral canals as evidenced by post-treatment CBCT scans. CBCT images will be analyzed and the size of the lesion will be measured and will be evaluated.
Change from baseline - Length of lateral canal filled at 6 months and 1 year
Time frame: 6 months and 1 year post treatment
The study will also evaluate how well the lateral canals are filled after irrigation with the new generation of negative irrigation pressure unit with and without the ultrasonic irrigation The amount of filling material visualized in each lateral canal will be calculated and expressed as a percentage of linear extension (length of the lateral canal that was filled, in relation to its entire length in mm).
Change from baseline - Area of the lateral canal filled at 6 months and 1 year
Time frame: 6 months and 1 year post treatment
The study will also measure the area occupied by the filling material inside the lateral canal in relation to its entire area in mm²).
1 secondary outcome
Change from baseline - Periapical radiographic healing
Time frame: 6 months and 1 year after endodontic therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- Individual participant dataSharing planned: No
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Effect of Temperature Elevation on the Antimicrobial Efficacy of Two Root Canal Irrigants in Primary Root Canal Infections: A Randomized Controlled Clinical Trial
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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.
Brett Gilbert, DDS principal investigator
King Endodontics, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigation Technique 1 and Irrigation Technique 2 in people with Root Canal Infection, run by KaVo Kerr at 1 site in United States.
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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Javier, MD ((714)-516-7680, Maria.Javier@kavokerr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline - Size of the lesion in the lateral canals at 1 year (time frame: 1 year after endodontic therapy). The study lists 3 primary outcomes in all. 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 27 Dec 2017.