Teeth, Endodontically-TreatedNCT00497042
Safety and Efficacy of Using the Endodontic Self Adjusting File - SAF for Root Canal Treatment
A study testing Self Adjusting File in people with Teeth, Endodontically-Treated, run by ReDent Nova at 1 site in Israel.
Trial summary
The study's primary goal is to assess the safety of the SAF (Self Adjusting File) device for root canal treatments. The study's secondary goal is to evaluate the effectiveness of the SAF device for root canal treatments Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Teeth, Endodontically-Treated
- What is being tested?
- Self Adjusting File
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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
- Subjects is 18 years or older
- Subject has one or more teeth that have to go through a root canal treatment
- Roots are fully formed and with a mature apex
- At least one of the roots to be treated has periapical radiolucency with a diameter of 2-6mm and a PAI score of 4 or 5
- Subject had signed the informed consent form
Who cannot join
- Previous root canal filling
- Roots with abnormal root canal anatomy
- Roots for which a good quality periapical radiographic image cannot be produced
- Un-restorable teeth
- Significant periodontal pockets
- Patients who are pregnant or breast-feeding
Show all 20Show fewer
- Uncontrolled systemic hypertension
- Severe uncontrolled Diabetes Mellitus
- Current steroid therapy in excess of prednisone 5 mg/day
- HIV positive patients
- Hepatitis
- Chronic renal failure
- Hematological disease (malignancy, severe anemia)
- Osteoporosis, receiving biphosphonates
- Post head and neck irradiation treatment
- Other severe or life-threatening systemic disease
- Known cognitive disorder, psychiatric and/or neurological disease
- Concurrent participation in any other clinical study
- Patients cannot understand or not willing to sign the informed consent
- During chemotherapy or radiology treatment
Trial locations and contacts
1 site in 1 country.
About this study
The study's primary goal is to assess the safety of the SAF (Self Adjusting File) device for root canal treatments.
The study's secondary goal is to evaluate the effectiveness of the SAF device for root canal treatments
Read the detailed description
Endodontic treatment (root canal treatment) is conducted when the dental pulp is inflamed or when it becomes necrotic and infected. The main cause for both these cases is dental caries and they represent sequential stages of the same disease with inflammation preceding the necrosis and infection.
Mechanically, both conditions are treated in a rather similar manner, by "cleaning and shaping", using endodontic files and irrigation solutions. This mechanical process is aimed to thoroughly disinfect the root canal by removing all tissue remnants while enlarging the diameter of the root canal, to remove all canal irregularities that may harbor bacteria. During this process an inner layer of dentin has to be removed from all the surface of the root canal. A second goal of root canal treatment is to allow adequate sealing of the canal space by a root canal filling, in order to prevent future bacterial contamination. For teeth with inflamed vital pulps, once this stage is completed the root canal may be sealed. When necrotic infected root canals are involved, this stage greatly reduces the bacterial load in the canal but an additional stage of disinfection by medicaments, sealed in the canal until the next appointment, may be required.
The SAF file is an endodontic file designed to be operated by a Profin dental low-speed hand-piece (W\&H, Burmoos / Salzburg, Austria), which converts rotation into a transline reciprocal movement. The active part of the file is manufactured from a thin-walled tube of medical grade nickel-titanium alloy. It has a cylindrical shape and can be compressed to allow its insertion into thin root canal, due to its lattice-like structure.
The SAF file is an endodontic file of a revolutionary design. As any endodontic file it is designed to remove dentin from the root canal walls and enlarge the canal. Its advantages are:
- it grinds the inner root canal wall, rather than machine-cut it,
- it adapts itself to the cross section of the canal and enlarges it to a wider version of its original form.
- It enlarges the canal; using one instrument which gradually expands in size, rather than tediously using a sequence of instruments.
- Its hollow space allows for continuous irrigation and flushing out the ground material rather than tediously stopping again and again to remove the instrument from the root canal and flush it, and
- it is highly resistant to breakage
The tested device is an engine-operated endodontic file used for root canal treatment. It is constructed from a medical grade nickel-titanium alloy and designed as a hollow tube made of a delicate metal lattice, attached to a dental hand-piece. It is operated in root canals with a continuous rinsing. The rinsing solution enters the hollow device through a special irrigator attachment, flows through the root canal and emerges through the access cavity, where it is collected using a dental suction tip.
- Conditions
- Teeth, Endodontically-Treated
- Being tested
- Self Adjusting File
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Adjusting FileDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment related operative and postoperative major complications.
Measured: One year.
Secondary outcomes (1)
Healing of pariapical leasions as a result of the endodontic treatment.
Measured: One year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teeth, Endodontically-TreatedStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReDent Nova
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Amnon Singer, DMD, Principal investigator, Redent Nova Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497042
- Sponsor's protocol ID
- TASMC-07-AS-030-CTIL
- Status last verified
- Jul 2007
- First submitted
- 4 Jul 2007
- Last updated
- 11 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Using the Endodontic Self Adjusting File - SAF for Root Canal Treatment
- ClinicalTrials.gov ID
- NCT00497042
- Acronym / sponsor ID
- TASMC-07-AS-030-CTIL
- Conditions
- Teeth, Endodontically-Treated
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ReDent NovaIndustry (pharma, biotech, devices)
- First posted
- 6 Jul 2007 (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 study's primary goal is to assess the safety of the SAF (Self Adjusting File) device for root canal treatments.
The study's secondary goal is to evaluate the effectiveness of the SAF device for root canal treatments
Detailed description
Endodontic treatment (root canal treatment) is conducted when the dental pulp is inflamed or when it becomes necrotic and infected. The main cause for both these cases is dental caries and they represent sequential stages of the same disease with inflammation preceding the necrosis and infection.
Mechanically, both conditions are treated in a rather similar manner, by "cleaning and shaping", using endodontic files and irrigation solutions. This mechanical process is aimed to thoroughly disinfect the root canal by removing all tissue remnants while enlarging the diameter of the root canal, to remove all canal irregularities that may harbor bacteria. During this process an inner layer of dentin has to be removed from all the surface of the root canal. A second goal of root canal treatment is to allow adequate sealing of the canal space by a root canal filling, in order to prevent future bacterial contamination. For teeth with inflamed vital pulps, once this stage is completed the root canal may be sealed. When necrotic infected root canals are involved, this stage greatly reduces the bacterial load in the canal but an additional stage of disinfection by medicaments, sealed in the canal until the next appointment, may be required.
The SAF file is an endodontic file designed to be operated by a Profin dental low-speed hand-piece (W\&H, Burmoos / Salzburg, Austria), which converts rotation into a transline reciprocal movement. The active part of the file is manufactured from a thin-walled tube of medical grade nickel-titanium alloy. It has a cylindrical shape and can be compressed to allow its insertion into thin root canal, due to its lattice-like structure.
The SAF file is an endodontic file of a revolutionary design. As any endodontic file it is designed to remove dentin from the root canal walls and enlarge the canal. Its advantages are:
- it grinds the inner root canal wall, rather than machine-cut it,
- it adapts itself to the cross section of the canal and enlarges it to a wider version of its original form.
- It enlarges the canal; using one instrument which gradually expands in size, rather than tediously using a sequence of instruments.
- Its hollow space allows for continuous irrigation and flushing out the ground material rather than tediously stopping again and again to remove the instrument from the root canal and flush it, and
- it is highly resistant to breakage
The tested device is an engine-operated endodontic file used for root canal treatment. It is constructed from a medical grade nickel-titanium alloy and designed as a hollow tube made of a delicate metal lattice, attached to a dental hand-piece. It is operated in root canals with a continuous rinsing. The rinsing solution enters the hollow device through a special irrigator attachment, flows through the root canal and emerges through the access cavity, where it is collected using a dental suction tip.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (5 listed)
- Subjects is 18 years or older
- Subject has one or more teeth that have to go through a root canal treatment
- Roots are fully formed and with a mature apex
- At least one of the roots to be treated has periapical radiolucency with a diameter of 2-6mm and a PAI score of 4 or 5
- Subject had signed the informed consent form
Key exclusion criteria (20 listed)
- Previous root canal filling
- Roots with abnormal root canal anatomy
- Roots for which a good quality periapical radiographic image cannot be produced
- Un-restorable teeth
- Significant periodontal pockets
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 |
|---|---|---|
| Self Adjusting File | Device | – |
Primary outcome
Treatment related operative and postoperative major complications.
Time frame: One year.
1 secondary outcome
Healing of pariapical leasions as a result of the endodontic treatment.
Time frame: One year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2007.
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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.
Amnon Singer, DMD principal investigator
Redent Nova Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Adjusting File in people with Teeth, Endodontically-Treated, run by ReDent Nova 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 5 inclusion and 20 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 11 Jul 2007. 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.
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 Amnon Singer, DMD (+972 52 4266927, asinger@inter.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment related operative and postoperative major complications. (time frame: One year.). 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 11 Jul 2007.