Effect of Three Mechanical Systems on Removal of Endotoxins From Necrotic Teeth (RCT2019)

Effect of Three Mechanical Systems on Removal of Endotoxins From Necrotic Teeth With Apical Periodontitis After Two-visit RCT

The patients will be randomly assigned into two equal groups Group : OneShape Group: ProtaperNext

Endodontics procedure steps:

Patient will be anesthetized by using infiltration local anesthesia or nerve block according to the tooth location in mandibular or maxillary arch respectively.

All caries will be removed, then isolation using rubber dam, the crown and surrounding structures will be disinfected with 30% H2O2( hydrogen peroxide) for 30 seconds, followed by 2.5% NaOCl for the same period of time and then inactivated with 5% sodium thiosulphate.

2- For the access cavity preparation, a sterile/apyrogenic high-speed diamond bur will be used in conjunction with manual irrigation with sterile saline. Before entering the pulp chamber, the access cavity will be disinfected according to the protocol described above.

2- Root canal length will be determined, by preoperative radiograph then (S1) will be taken by introducing a sterile/apyrogenic paper point #15/ 20 (5paper points) into the full length of the canal and left there for 1 minute. Then, the sample will be placed in an apyrogenic glass and stored in -20°. Then canal length will be confirmed by apex locator.

3- Cleaning and shaping will be done using either One shape or Protaper next rotary instruments in crown down preparation technique with the use of in an endodontic motor according to the manufacturer instructions, the canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every subsequent instrument.

Lab procedures to identify microorganisms

Study Overview

• Status: Unknown
• Conditions: Endodontic Disease
• Intervention / Treatment: Diagnostic test: ProTaper Next

Detailed Description

The patients will be randomly assigned into two equal groups Group : OneShape Group: ProtaperNext

Endodontics procedure steps:

Patient will be anesthetized by using infiltration local anesthesia or nerve block according to the tooth location in mandibular or maxillary arch respectively.

All caries will be removed, then isolation using rubber dam, the crown and surrounding structures will be disinfected with 30% H2O2( hydrogen peroxide) for 30 seconds, followed by 2.5% NaOCl for the same period of time and then inactivated with 5% sodium thiosulphate.

2- For the access cavity preparation, a sterile/apyrogenic high-speed diamond bur will be used in conjunction with manual irrigation with sterile saline. Before entering the pulp chamber, the access cavity will be disinfected according to the protocol described above.

2- Root canal length will be determined, by preoperative radiograph then (S1) will be taken by introducing a sterile/apyrogenic paper point #15/ 20 (5paper points) into the full length of the canal and left there for 1 minute. Then, the sample will be placed in an apyrogenic glass and stored in -20°. Then canal length will be confirmed by apex locator.

3- Cleaning and shaping will be done using either One shape or Protaper next rotary instruments in crown down preparation technique with the use of in an endodontic motor according to the manufacturer instructions, the canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every subsequent instrument.

4-After root canal preparation, NaOCl will be inactivated with 5 mL of sterile 5% sodium thiosulphate for 1 minute, which then will be removed with 5 mL of sterile/apyrogenic saline solution., which then will be removed with 5 mL of sterile/apyrogenic saline solution. second endotoxin sample (S2) will be taken from the root canals. (5 paper point size of the master cone).

5- After completion of instrumentation and irrigation, obturation will be done using size 30/ 0.4 taper gutta-percha cones and auxiliaries as needed using the modified single cone technique.

Determination of Endotoxin Concentration Human endotoxin (ET) ELISA Kit will be used to measure endotoxin concentrations in the root canals before and after chemomechanical procedures.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • BC
    • Tijuana, BC, Mexico, 22000
      • Jorge Paredes Vieyra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The inclusion limitations were:

  1. nonappearance of radiographic proof of apical inflammation.
  2. irreversible pulpitis recognized by the positive reaction to thermal tests, and
  3. persistent pre-operative pain due to the pulpal condition.
  4. Patients must be in physical and emotional wellbeing.
  5. Any drug used seven days' previous study.

Exclusion Criteria:

1. impossibility to obtain patient's consent,
2. patients younger than 18 years. Necrotic teeth and teeth with periapical injury, root resorption,
3. Patients rejecting to join the research, those with issues with single-visit RCT, those consuming a specific kind of medicine such as painkillers or NSAIDs, and participants with some unrestrained systemic ailment were excluded too.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ProTaper Next group; Clean and shape the necrotic canals with ProTaper instruments. In case of pain or inflammation 800mg Ibuprofen 3 times a day	Diagnostic test: ProTaper Next; The canal fluid sample before and after will evaluate after root canal instrumentation
Experimental: WaveOne Gold group; Clean and shape the necrotic canals with Wave One Gold instruments. In case of pain or inflammation 800mg Ibuprofen 3 times a day	Diagnostic test: ProTaper Next; The canal fluid sample before and after will evaluate after root canal instrumentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endotoxin test for both groups	measure endotoxin concentrations in the root canals before and after chemomechanical procedures. 24 hrs after root canal treatment	Endotoxin from fluid in ProTaper Next group

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Baja California

Publications and helpful links

General Publications

• Paredes-Vieyra J, Enriquez FJ. Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial. J Endod. 2012 Sep;38(9):1164-9. doi: 10.1016/j.joen.2012.05.021. Epub 2012 Jul 26.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2019
• Primary Completion (Actual): September 13, 2019
• Study Completion (Anticipated): December 6, 2019

Study Registration Dates

• First Submitted: December 8, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases
• Other Study ID Numbers: ENDO2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Clean and shape with two kinds of Ni-Ti instruments

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No