Root Canal Disinfection: a Comparison Between Techniques

NCT03490526 | Unknown

• 1 other identifier: PPGO0024
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontically Treated Teeth

Outcome Measures

Primary Outcomes (1)

• Periradicular repair

  This outcome will be evaluated radiographically by one calibrated examiner.

  2 years

Secondary Outcomes (1)

• Quality of endodontic treatment

  2 years

Study Arms (2)

Root canal disinfection with XP-endo Finisher

EXPERIMENTAL

Device: Root canal disinfection with XP-endo Finisher

Root canal disinfection with passive ultrasonic irrigation

ACTIVE COMPARATOR

Device: Root canal disinfection with passive ultrasonic irrigation

Interventions

Root canal disinfection with XP-endo Finisher DEVICE

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

Root canal disinfection with XP-endo Finisher

Root canal disinfection with passive ultrasonic irrigation DEVICE

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.

Root canal disinfection with passive ultrasonic irrigation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or more;
• good general healthy;
• molars or premolar requiring endodontic treatment;
• at least 20 teeth;

You may not qualify if:

• root fracture;
• injury involving the furcation region
• need to behave as a prosthetic abutment;
• mobility greater than degree I;

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96015560, Brazil

Location

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: April 6, 2018
• Study Start: May 2, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2020
• Last Updated: April 6, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)