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

NCT00497042 | Unknown DMC

• 1 other identifier: TASMC-07-AS-030-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Teeth, Endodontically-Treated

Outcome Measures

Primary Outcomes (1)

• Treatment related operative and postoperative major complications.

  One year.

Secondary Outcomes (1)

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

  One year.

Interventions

Self Adjusting File DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• ReDent Nova: lead

Study Sites (1)

Tel Aviv Souraski Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Amnon Singer, DMD

  Redent Nova Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amnon Singer, DMD

CONTACT

+972 52 4266927; asinger@inter.net.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 4, 2007
• First Posted: July 6, 2007
• Last Updated: July 11, 2007

Record last verified: 2007-07

Locations

IL (1)