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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by ReDent Nova.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
ReDent Nova
ClinicalTrials.gov Identifier:
NCT00497042
First received: July 4, 2007
Last updated: July 10, 2007
Last verified: July 2007
  Purpose

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


Condition Intervention
Teeth, Endodontically-Treated
Device: Self Adjusting File

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Using the Endodontic Self Adjusting File - SAF for Root Canal Treatment

Further study details as provided by ReDent Nova:

Primary Outcome Measures:
  • Treatment related operative and postoperative major complications. [ Time Frame: One year. ]

Secondary Outcome Measures:
  • Healing of pariapical leasions as a result of the endodontic treatment. [ Time Frame: One year. ]

Estimated Enrollment: 100
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497042

Contacts
Contact: Amnon Singer, DMD +972 52 4266927 asinger@inter.net.il

Locations
Israel
Tel Aviv Souraski Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
ReDent Nova
Investigators
Principal Investigator: Amnon Singer, DMD Redent Nova Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00497042     History of Changes
Other Study ID Numbers: TASMC-07-AS-030-CTIL
Study First Received: July 4, 2007
Last Updated: July 10, 2007
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Tooth, Nonvital
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 30, 2014