Dental Pulp CavityPhase 1NCT01192607
Endoscopic Treatment During Endodontic Procedures
A Phase 1 study testing Endoscopic treatment during root canal treatment in people with Dental Pulp Cavity and Root Canal Treatment, run by Barzilai Medical Center at 1 site in Israel.
Trial summary
The objectives of this Phase I study is to evaluate the safety and effectiveness of the endoscopic endodontic equipment device for root canal assistance treatment as well as to evaluate the ease of use of this device, by a surgeon experienced in endodontic treatment, in a true clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Cavity, Root Canal Treatment, Endoscopy
- What is being tested?
- Endoscopic treatment during root canal treatment
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2007to Aug 2015
- Phase
- Phase 1
- 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
- Over 18 years old
- Suffers from deep carries, acute or chronic pulpitis crown fracture which root canal treatment is the treatment of choice.
- Patient understands and has signed the Informed Consent Form.
Who cannot join
- Teeth with cracks or root fracture.
- Patients on anti-coagulants.
- Patients with cardiac diseases, kidney insufficiency, any malignancy or any steroid therapy.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Oral and Maxillofacial Surgery, Barzilai Medical Center
Ashkelon, 78306
About this study
The objectives of this Phase I study is to evaluate the safety and effectiveness of the endoscopic endodontic equipment device for root canal assistance treatment as well as to evaluate the ease of use of this device, by a surgeon experienced in endodontic treatment, in a true clinical setting.
Read the detailed description
This open, phase 1 trial will be conducted on 15 patients with the need for root canal treatment. The teeth will be permanent teeth in which the need for root canal treatment was decided by his dentist in the dental clinic in the Barzilai medical center Ashkelon. Videoendoscopy of the procedure will be recorded and will include a post-op view of the treatment. Patients will be followed up for pain infection and any potential complications; immediately, at 4 weeks 12 weeks and 6 month post- op. The procedure will also be taped externally to document surgeon's convenience with the equipment.
The procedures will be performed under local or general anesthesia in an ambulatory environment, using standard root canal equipment, which will include endodontic hand and rotary files, endodonically used irrigating solutions and the videoendoscopy equipment. Under this protocol the basic treatment will be carried out by professional well trained endodontist in the same way used for root canal treatment. Following the mechanical preparation of the canal the endoscope, connected to a video camera and monitor, is introduced with the help of isotonic saline irrigation. With the aid of the endoscope remains of soft tissue from the pulp tissue will be coagulated with the ERBOTOM ICC 80 monopolar fibers and removed with the irrigation, the canal will be inspected for lateral canals and the monoplar fibers will be used for coagulating and removal of this tissue. Er-Yag laser fiber connected to Erbium laser generator will be used for finalizing the canal preparation and preparation of the lateral canals. Actual lasing and coagulation will be performed only under clear vision, when the fiber is seen to be in direct contact with the tissue. Adequate irrigation will be maintained throughout the procedure using an intravenous bag connected to the irrigation port on the sheath of the endoscope.
The endoscope device will be connected to the Erbbe diathermy ERBOTOM ICC 80 for coagulation monopolar fibers 0.05-0.1 mm number 20197-021-022 .
Standard Lumenis Opus 20, dental Erbium:YAG laser available in the hospital. Lasing will begin at a setting of 300 mj per pulse and a pulse rate of 7 Hz.
The same procedures performed on 15 human teeth in a lab status. The insertion of the instruments to the root canal will be in 2 techniques:1) Via the endoscope channel and 2) The instruments will be inserted parallel to the endoscope.
- Conditions
- Dental Pulp Cavity, Root Canal Treatment, Endoscopy
- Being tested
- Endoscopic treatment during root canal treatment
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic treatment during root canal treatmentDevice
Endoscopic treatment during root canal treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic root canal treatment
Measured: 1 month
Secondary outcomes (1)
Endoscopic root canal complications
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startApr 2007
- Primary completionNov 2007
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp CavityStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barzilai Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Oded Nahlieli, DMD, Principal investigator, Barzilai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192607
- Sponsor's protocol ID
- HTA3741
- Other IDs
- BAR1404CTIL
- Status last verified
- Mar 2011
- First submitted
- 31 Aug 2010
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Treatment During Endodontic Procedures
- ClinicalTrials.gov ID
- NCT01192607
- Acronym / sponsor ID
- HTA3741
- Conditions
- Dental Pulp Cavity, Root Canal Treatment, Endoscopy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Barzilai Medical CenterUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 Sep 2010 (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.
The objectives of this Phase I study is to evaluate the safety and effectiveness of the endoscopic endodontic equipment device for root canal assistance treatment as well as to evaluate the ease of use of this device, by a surgeon experienced in endodontic treatment, in a true clinical setting.
Detailed description
This open, phase 1 trial will be conducted on 15 patients with the need for root canal treatment. The teeth will be permanent teeth in which the need for root canal treatment was decided by his dentist in the dental clinic in the Barzilai medical center Ashkelon. Videoendoscopy of the procedure will be recorded and will include a post-op view of the treatment. Patients will be followed up for pain infection and any potential complications; immediately, at 4 weeks 12 weeks and 6 month post- op. The procedure will also be taped externally to document surgeon's convenience with the equipment.
The procedures will be performed under local or general anesthesia in an ambulatory environment, using standard root canal equipment, which will include endodontic hand and rotary files, endodonically used irrigating solutions and the videoendoscopy equipment. Under this protocol the basic treatment will be carried out by professional well trained endodontist in the same way used for root canal treatment. Following the mechanical preparation of the canal the endoscope, connected to a video camera and monitor, is introduced with the help of isotonic saline irrigation. With the aid of the endoscope remains of soft tissue from the pulp tissue will be coagulated with the ERBOTOM ICC 80 monopolar fibers and removed with the irrigation, the canal will be inspected for lateral canals and the monoplar fibers will be used for coagulating and removal of this tissue. Er-Yag laser fiber connected to Erbium laser generator will be used for finalizing the canal preparation and preparation of the lateral canals. Actual lasing and coagulation will be performed only under clear vision, when the fiber is seen to be in direct contact with the tissue. Adequate irrigation will be maintained throughout the procedure using an intravenous bag connected to the irrigation port on the sheath of the endoscope.
The endoscope device will be connected to the Erbbe diathermy ERBOTOM ICC 80 for coagulation monopolar fibers 0.05-0.1 mm number 20197-021-022 .
Standard Lumenis Opus 20, dental Erbium:YAG laser available in the hospital. Lasing will begin at a setting of 300 mj per pulse and a pulse rate of 7 Hz.
The same procedures performed on 15 human teeth in a lab status. The insertion of the instruments to the root canal will be in 2 techniques:1) Via the endoscope channel and 2) The instruments will be inserted parallel to the endoscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old
- Suffers from deep carries, acute or chronic pulpitis crown fracture which root canal treatment is the treatment of choice.
- Patient understands and has signed the Informed Consent Form.
Key exclusion criteria (3 listed)
- Teeth with cracks or root fracture.
- Patients on anti-coagulants.
- Patients with cardiac diseases, kidney insufficiency, any malignancy or any steroid therapy.
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 |
|---|---|---|
| Endoscopic treatment during root canal treatmentEndoscopic treatment during root canal treatment | Device | – |
Primary outcome
Endoscopic root canal treatment
Time frame: 1 month
1 secondary outcome
Endoscopic root canal complications
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
Related trials for Dental Pulp Cavity
Recruiting
Effect of Cavity Disinfectants on Post Operative Pain & Success of Partial Caries Removal
Pulp Disease, Dental
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.
Oded Nahlieli, DMD principal investigator
Barzilai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Endoscopic treatment during root canal treatment in people with Dental Pulp Cavity and Root Canal Treatment, run by Barzilai Medical Center at 1 site in Israel.
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 3 inclusion and 3 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 17 Jan 2019. 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 Israel. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Endoscopic root canal treatment (time frame: 1 month). 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 17 Jan 2019.