Effect of Three Mechanical Systems on Removal of Endotoxins From Necrotic Teeth

Endodontic Disease Clinical Trial

— RCT2019  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04200638
• Other study ID #: ENDO2020
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 10, 2019
• Est. completion date: December 6, 2019

Study information

• Verified date: December 2019
• Source: Universidad Autonoma de Baja California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 6, 2019
• Est. primary completion date: September 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease

Intervention

Diagnostic Test:
• ProTaper Next
The canal fluid sample before and after will evaluate after root canal instrumentation

Locations

Country	Name	City	State
Mexico	Jorge Paredes Vieyra	Tijuana	BC

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Baja California

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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