Endoscopic Treatment During Endodontic Procedures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Barzilai Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Barzilai Medical Center
ClinicalTrials.gov Identifier:
NCT01192607
First received: August 31, 2010
Last updated: March 1, 2011
Last verified: March 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Treatment During Endodontic Procedures

Resource links provided by NLM:


Further study details as provided by Barzilai Medical Center:

Primary Outcome Measures:
  • Endoscopic root canal treatment [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Endoscopic root canal complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: April 2007
Estimated Study Completion Date: December 2011
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Endoscopic treatment during root canal treatment
    Endoscopic treatment during root canal treatment
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.

  Eligibility

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

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.
  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: NCT01192607

Contacts
Contact: Oded Nahlieli, DMD 972 524351116 nahlieli@yahoo.com

Locations
Israel
Oral and Maxillofacial Surgery, Barzilai Medical Center Recruiting
Ashkelon, Israel, 78306
Contact: Oded Nahlieli, DMD    972 524351116    nahlieli@yahoo.com   
Sponsors and Collaborators
Barzilai Medical Center
Investigators
Principal Investigator: Oded Nahlieli, DMD Barzilai Medical Center
  More Information

No publications provided

Responsible Party: oded nahlieli, OMFS BARZILAI MEDICAL CENTER
ClinicalTrials.gov Identifier: NCT01192607     History of Changes
Other Study ID Numbers: HTA3741, BAR1404CTIL
Study First Received: August 31, 2010
Last Updated: March 1, 2011
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on September 14, 2014