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

NCT04200638 | Unknown DMC

• 1 other identifier: ENDO2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Endodontic Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ProTaper Next group

EXPERIMENTAL

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

WaveOne Gold group

EXPERIMENTAL

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

Interventions

ProTaper Next DIAGNOSTIC_TEST

The canal fluid sample before and after will evaluate after root canal instrumentation

ProTaper Next group; WaveOne Gold group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: 18 to 65 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• impossibility to obtain patient's consent,
• patients younger than 18 years. Necrotic teeth and teeth with periapical injury, root resorption,
• 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.

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

Study Sites (1)

Jorge Paredes Vieyra

Tijuana, Estado de Baja California, 22000, Mexico

Location

Related 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.

  PMID: 22892729 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, investigator and assessor.The trial design of this study will be a prospective, parallel.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Jorge Paredes Vieyra DDS, MsC, PhD

Model Details: The trial design of this study will be a prospective, parallel, Randomized clinical trial (RCT).

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: December 16, 2019
• Study Start: February 10, 2019
• Primary Completion: September 13, 2019
• Study Completion: December 6, 2019
• Last Updated: December 16, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)