Root Canal Disinfection: a Comparison Between Techniques
Primary Purpose
Endodontically Treated Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Root canal disinfection with XP-endo Finisher
Root canal disinfection with passive ultrasonic irrigation
Sponsored by
About this trial
This is an interventional treatment trial for Endodontically Treated Teeth
Eligibility Criteria
Inclusion Criteria:
- 18 years old or more;
- good general healthy;
- molars or premolar requiring endodontic treatment;
- at least 20 teeth;
Exclusion Criteria:
- root fracture;
- injury involving the furcation region
- need to behave as a prosthetic abutment;
- mobility greater than degree I;
Sites / Locations
- Federal University of Pelotas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Root canal disinfection with XP-endo Finisher
Root canal disinfection with passive ultrasonic irrigation
Arm Description
Outcomes
Primary Outcome Measures
Periradicular repair
This outcome will be evaluated radiographically by one calibrated examiner.
Secondary Outcome Measures
Quality of endodontic treatment
This outcome will be evaluated through a radiograph by one calibrated examiner.
Full Information
NCT ID
NCT03490526
First Posted
March 15, 2018
Last Updated
April 5, 2018
Sponsor
Federal University of Pelotas
1. Study Identification
Unique Protocol Identification Number
NCT03490526
Brief Title
Root Canal Disinfection: a Comparison Between Techniques
Official Title
Comparison Between Two Different Techniques of Root Canal Disinfection (XP-endo Finisher Versus Passive Ultrasonic Irrigation): Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2018 (Anticipated)
Primary Completion Date
April 30, 2019 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Pelotas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Caries disease is still the leading cause of severe tooth decay. Since this can lead to tooth loss, it is important that appropriate treatment is advised to help prevent damage and maintain tooth health. Faced with major coronary destruction, several times it becomes necessary to perform the endodontic treatment, aiming to maintain the element in the buccal cavity for longer. It is known that an excellent restorative treatment with poor endodontic treatment and vice versa has a direct impact on the (in) success of the treatment. In this context, the proper cleaning of the root canals is highlighted, aiming the removal of bacteria and toxins. There are several cleaning methods described in the literature, but it is not yet known which would be the most effective in the removal of these contaminants. In this double-blind randomized clinical trial, patients who need and meet the inclusion criteria will undergo endodontic treatment in two different root canal cleansing techniques (passive ultrasonic cleaning and cleaning with the XP Endo device). Patients will be monitored annually after finish your endodontic treatment to evaluate the periradicular repair and the quality of endodontic treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Root canal disinfection with XP-endo Finisher
Arm Type
Experimental
Arm Title
Root canal disinfection with passive ultrasonic irrigation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Root canal disinfection with XP-endo Finisher
Intervention Description
The XP-Endo® finisher will be used next to the X-Smart Plus endodontic motor, with speed settings at 800rpm and torque at 1 N.cm. Irrigation with 17% EDTA and 2.5% NaOCl will be performed in three cycles of one minute each. In each cycle the XP-Endo will be used in the working length in continuous and slow movements of entrance and exit, with amplitude of 5mm, for a period of 1 minute, followed by new irrigation with 2.5ml of EDTA solution or hypochlorite of sodium 2,5%. Finally, the channel will be completely dry with absorbent paper tips
Intervention Type
Device
Intervention Name(s)
Root canal disinfection with passive ultrasonic irrigation
Intervention Description
For cleaning using passive ultrasonic irrigation, the E1 Irrisonic tip (Helse Ultrasonic, Ribeirão Preto, SP), will be used with Jetlaxis Sonic BP LED (Schuster, Santa Maria, RS). The insert has a diameter equivalent to a manual file 20, with reduced taper (0.01). The power used will be 10%. With root canals flooded with 17% EDTA, the irrigation tips will be coupled to the ultrasound and 1mm shorter than the working length. These tips will be kept in the center of the canal avoiding contact with the dentin walls. The irrigation will be performed in three cycles, and in each cycle the irrigation tips will be activated for 1 minute followed by new irrigation with 2.5ml EDTA. The same procedure will be repeated with 2.5% NaoCl. Finally, the channel will be completely dry with absorbent paper tips.
Primary Outcome Measure Information:
Title
Periradicular repair
Description
This outcome will be evaluated radiographically by one calibrated examiner.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Quality of endodontic treatment
Description
This outcome will be evaluated through a radiograph by one calibrated examiner.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years old or more;
good general healthy;
molars or premolar requiring endodontic treatment;
at least 20 teeth;
Exclusion Criteria:
root fracture;
injury involving the furcation region
need to behave as a prosthetic abutment;
mobility greater than degree I;
Facility Information:
Facility Name
Federal University of Pelotas
City
Pelotas
State/Province
Rio Grande Do Sul
ZIP/Postal Code
96015560
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana Pereira Cenci, PhD
Phone
53 981114509
Email
tatiana.dds@gmail.com
First Name & Middle Initial & Last Name & Degree
Fernanda Geraldo Pappen, PhD
Phone
53 32256741
Email
ferpappen@gmail.com
First Name & Middle Initial & Last Name & Degree
Juliana LS Uehara, Dds
12. IPD Sharing Statement
Plan to Share IPD
No
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Root Canal Disinfection: a Comparison Between Techniques
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