CClinicalTrials.gg
Status unknownNCT00497042Updated Jul 11, 2007

Safety and Efficacy of Using the Endodontic Self Adjusting File - SAF for Root Canal Treatment

An interventional study of Self Adjusting File in Teeth, Endodontically-Treated, sponsored by ReDent Nova. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-07-11.

Sponsored by ReDent Nova · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2007), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Teeth, Endodontically-Treated

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03

In context

Tooth, Nonvital

113 studies on the registry are indexed under Tooth, Nonvital; 19 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 103 interventional studies indexed under Tooth, Nonvital.

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Lead sponsor

This is the only study on the registry with ReDent Nova as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Subjects is 18 years or older
  2. Subject has one or more teeth that have to go through a root canal treatment
  3. Roots are fully formed and with a mature apex
  4. 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
  5. Subject had signed the informed consent form

Exclusion criteria

Exclusion Criteria:

  1. Previous root canal filling
  2. Roots with abnormal root canal anatomy
  3. Roots for which a good quality periapical radiographic image cannot be produced
  4. Un-restorable teeth
  5. Significant periodontal pockets
  6. Patients who are pregnant or breast-feeding
  7. Uncontrolled systemic hypertension
  8. Severe uncontrolled Diabetes Mellitus
  9. Current steroid therapy in excess of prednisone 5 mg/day
  10. HIV positive patients
  11. Hepatitis
  12. Chronic renal failure
  13. Hematological disease (malignancy, severe anemia)
  14. Osteoporosis, receiving biphosphonates
  15. Post head and neck irradiation treatment
  16. Other severe or life-threatening systemic disease
  17. Known cognitive disorder, psychiatric and/or neurological disease
  18. Concurrent participation in any other clinical study
  19. Patients cannot understand or not willing to sign the informed consent
  20. During chemotherapy or radiology treatment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Interventions

  • DeviceSelf Adjusting File
06

What researchers measure

Primary outcomes

  1. Treatment related operative and postoperative major complications.

    Time frame: One year.

Secondary outcomes

  1. Healing of pariapical leasions as a result of the endodontic treatment.

    Time frame: One year.

07

Study locations

1 site
  • Tel Aviv Souraski Medical Center
    Tel Aviv, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00497042
Lead sponsor
ReDent Nova
First posted
Jul 6, 2007
Last update
Jul 11, 2007

Study contacts

Amnon Singer, DMD
Contact
asinger@inter.net.il
+972 52 4266927
Amnon Singer, DMD
principal investigator · Redent Nova Ltd.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.

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