Endoscopic Treatment During Endodontic Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01192607
Recruitment Status : Unknown
Verified March 2011 by Barzilai Medical Center.
Recruitment status was:  Recruiting
First Posted : September 1, 2010
Last Update Posted : March 2, 2011
Information provided by:
Barzilai Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Dental Pulp Cavity Root Canal Treatment Endoscopy Device: Endoscopic treatment during root canal treatment Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Treatment During Endodontic Procedures
Study Start Date : April 2007
Actual Primary Completion Date : November 2007
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Intervention Details:
  • Device: Endoscopic treatment during root canal treatment
    Endoscopic treatment during root canal treatment

Primary Outcome Measures :
  1. Endoscopic root canal treatment [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Endoscopic root canal complications [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Over 18 years old
  2. Suffers from deep carries, acute or chronic pulpitis crown fracture which root canal treatment is the treatment of choice.
  3. Patient understands and has signed the Informed Consent Form.

Exclusion Criteria:

  1. Teeth with cracks or root fracture.
  2. Patients on anti-coagulants.
  3. Patients with cardiac diseases, kidney insufficiency, any malignancy or any steroid therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01192607

Contact: Oded Nahlieli, DMD 972 524351116

Oral and Maxillofacial Surgery, Barzilai Medical Center Recruiting
Ashkelon, Israel, 78306
Contact: Oded Nahlieli, DMD    972 524351116   
Sponsors and Collaborators
Barzilai Medical Center
Principal Investigator: Oded Nahlieli, DMD Barzilai Medical Center

Responsible Party: oded nahlieli, OMFS BARZILAI MEDICAL CENTER Identifier: NCT01192607     History of Changes
Other Study ID Numbers: HTA3741
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: March 2, 2011
Last Verified: March 2011