Effect of Different Root Canal Instruments on Removal of Endotoxins From Necrotic Root Canals

NCT03641612 | Completed

• 1 other identifier: CEBD-CU-2018-8-17
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

• Grouping: 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.

Conditions

Endodontic Disease

Keywords

rotary instruments; endotoxins

Outcome Measures

Primary Outcomes (1)

• endotoxin change

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

  Samples will be collected before and after chemomechanical preparation over 2 months

Study Arms (2)

one shape

EXPERIMENTAL

single file rotary system

Other: one shape

protaper next

ACTIVE COMPARATOR

multiple file rotary system

Other: protaper next

Interventions

one shape OTHER

canal fluid sample before and after root canal instrumentation

one shape

protaper next OTHER

canal fluid sample before and after root canal instrumentation

protaper next

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who are medically free and good health.
• Patient 's age between 20-60years.
• Patients with posterior teeth diagnosed clinically and confirmed by thermal sensitivity tests as teeth with necrotic pulp.
• Positive patient's acceptance for participation in the study.

You may not qualify if:

• Pregnancy or lactation
• Medically compromised patients -Patients aged less than20 or more than 60 years.-
• Patients unable to give informed consent.
• Previous endodontic therapy of the affected tooth .
• Teeth diagnosed with vital pulp.
• Teeth with periodontal pocket more than 3mm deep.
• Teeth with abnormal anatomy and calcified canals.
• Teeth with caries below the bony level (non-restorable tooth).
• Teeth with periapical swelling or sinus tract.

Sponsors & Collaborators

• Heba Elasfouri: lead

Study Sites (1)

Cairo University Faculty of Dentistry

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• heba elasfouri, lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

• marwa bedier, lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of endodontics- faculty of dentistry- cairo university

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

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 22, 2018
• Study Start: August 10, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 10, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

EG (1)