NCT01192607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 17, 2019

Status Verified

March 1, 2011

Enrollment Period

7 months

First QC Date

August 31, 2010

Last Update Submit

January 16, 2019

Conditions

Dental Pulp CavityRoot Canal TreatmentEndoscopy

Outcome Measures

Primary Outcomes (1)

  • Endoscopic root canal treatment

    1 month

Secondary Outcomes (1)

  • Endoscopic root canal complications

    1 month

Interventions

Endoscopic treatment during root canal treatmentDEVICE

Endoscopic treatment during root canal treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oral and Maxillofacial Surgery, Barzilai Medical Center

Ashkelon, 78306, Israel

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Oded Nahlieli, DMD

    Barzilai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2010

First Posted

September 1, 2010

Study Start

April 1, 2007

Primary Completion

November 1, 2007

Study Completion

August 1, 2015

Last Updated

January 17, 2019

Record last verified: 2011-03

Locations

IL(1)