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Root Canal Disinfection: a Comparison Between Techniques

Sponsor
Federal University of Pelotas (Other)
Overall Status
Unknown status
CT.gov ID
NCT03490526
Collaborator
(none)
25
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Root canal disinfection with XP-endo Finisher
  • Device: Root canal disinfection with passive ultrasonic irrigation
 N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
May 2, 2018
Anticipated Primary Completion Date :
Apr 30, 2019
Anticipated Study Completion Date :
Apr 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Periradicular repair [2 years]

    This outcome will be evaluated radiographically by one calibrated examiner.

Secondary Outcome Measures

  1. Quality of endodontic treatment [2 years]

    This outcome will be evaluated through a radiograph by one calibrated examiner.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Federal University of Pelotas Pelotas Rio Grande Do Sul Brazil 96015560

Sponsors and Collaborators

  • Federal University of Pelotas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maximiliano Sergio Cenci, PhD, Federal University of Pelotas
ClinicalTrials.gov Identifier:
NCT03490526
Other Study ID Numbers:
  • PPGO0024
First Posted:
Apr 6, 2018
Last Update Posted:
Apr 6, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Tooth, Nonvital

Study Results

No Results Posted as of Apr 6, 2018