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Root Canal Disinfection: a Comparison Between Techniques

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490526
Recruitment Status : Not yet recruiting
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Maximiliano Sergio Cenci, Federal University of Pelotas

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.

Condition or disease Intervention/treatment Phase
Endodontically Treated Teeth Device: Root canal disinfection with XP-endo Finisher Device: Root canal disinfection with passive ultrasonic irrigation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Two Different Techniques of Root Canal Disinfection (XP-endo Finisher Versus Passive Ultrasonic Irrigation): Randomized Clinical Trial
Estimated Study Start Date : May 2, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Root canal disinfection with XP-endo Finisher Device: Root canal disinfection with XP-endo Finisher
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

Active Comparator: Root canal disinfection with passive ultrasonic irrigation Device: Root canal disinfection with passive ultrasonic irrigation
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 Measures :
  1. Periradicular repair [ Time Frame: 2 years ]
    This outcome will be evaluated radiographically by one calibrated examiner.


Secondary Outcome Measures :
  1. Quality of endodontic treatment [ Time Frame: 2 years ]
    This outcome will be evaluated through a radiograph by one calibrated examiner.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;

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 ClinicalTrials.gov identifier (NCT number): NCT03490526


Locations
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Brazil
Federal University of Pelotas
Pelotas, Rio Grande Do Sul, Brazil, 96015560
Contact: Tatiana Pereira Cenci, PhD    53 981114509    tatiana.dds@gmail.com   
Contact: Fernanda Geraldo Pappen, PhD    53 32256741    ferpappen@gmail.com   
Sub-Investigator: Juliana LS Uehara, Dds         
Sponsors and Collaborators
Federal University of Pelotas

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Responsible Party: Maximiliano Sergio Cenci, PhD, Federal University of Pelotas
ClinicalTrials.gov Identifier: NCT03490526    
Other Study ID Numbers: PPGO0024
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tooth, Nonvital
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases