Evaluation of Post-endodontic Pain After Root Canal Treatment With Two Rotary Systems : Mtwo & Safe-sider

Post-endodontic pain (PP) still is major problem for endodontic patients, analgesics are routinely prescribed. Incidence of PP is reported extensively, and reviewed. PP is a complicated multi factorial process and is affected by factors related to patients, to the tooth and to the skills and experience of the dentist and because of that, if the interrelation of these factors is not considered in a PP, study data might be confusing. Any study trying to evaluate the effect of a specific technique or new device in the incidence or characteristics of PP should control all the confounding factors that have been described to be involved in the tested outcome.

reports mention a variable prevalence of PP, ranging from 82.9 to 10.6%. These variations are because of the differences in study methods, and treatment procedures after root canal treatment, selection of patients or experience and skills of the dentists, vary when different studies are compared.

Many studies had confirmed that chemomechanical debridement of the root canal results in extrusion of dentinal chips, pulp tissue fragments, necrotic tissues, microorganisms, and root canal irrigants through the apical foramen. All preparation techniques and instruments, regardless of maintaining shorter working length of the apical terminus have reported to be related with extrusion of infected debris, and some of them extruded less material and others extruded more.

Periapical inflammation and postoperative flare-ups may result from apical extrusion of debris that is also referred to as the "worm" of necrotic debris A common outcome of the studies examining the amount of apically extruded debris was that the techniques involving a push-pull filing motion usually produce a greater mass of apical debris than those have rotational action Files which has reciprocating and in-and-out filing motion, may act as a piston, extruding more debris and irrigants. While the file with continuous rotation motion like a screw conveyor improving transportation of dentinal chips and debris coronally.

In this study, investigators compare post-endodontic pain between these two systems. Mtwo ( continuous rotation system) with safe-sider (reciprocating system). Therefore, the aim of this study is Evaluation of post-endodontic pain after root canal treatment with two rotary systems: Mtwo & safe-sider

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: mtwo rotary system; Procedure: safe-sider rotary system; Procedure: hand files

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: arezoo hooshmandi, postgraduate; Phone Number: 00989177089315; Email: hooshmandi_arezoo@yahoo.com

Study Locations

• Iran, Islamic Republic of
  • Sistan and Baloochestan
    • Zahedan, Sistan and Baloochestan, Iran, Islamic Republic of, 98176699693
      • Recruiting
      • Zahedan University of Medical Science
      • Contact: arezoo hooshmandi, postgraduate; Phone Number: 00989177089315; Email: hooshmandi_arezoo@yahoo.com
      • Sub-Investigator: rohollah havaei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age range 20-50 years
• the systemically healthy
• first or second molar teeth require root canal therapy
• irreversible Pulpitis signed without the apical
• root canal curvature of less than 25 degrees, according to Schneider techniques

Exclusion Criteria:

• Root canal treatment,
• history of medication (antibiotics, NSAID, opiates) of the patient 12 hours before treatment ,
• pregnancy,
• complex anatomy,
• channels blocked in the x-ray plate,
• internal and external resorption,
• open apex teeth,
• periodontal disease,
• inflammation and abscesses,
• sinus tract,
• presence of radiographic lesions,
• tooth sensitivity to percussion,
• absence of occlusal contact .

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mtwo rotary system; ( continuous rotation system)	Procedure: mtwo rotary system; post-treatment pain after using mtwo rotary system
Experimental: safe-sider rotary system; (reciprocating system)	Procedure: safe-sider rotary system; post-treatment pain after using safe-sider rotary system
Experimental: hand files; k-files	Procedure: hand files; post-treatment pain after using hand files

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Information regarding post-operation pain is gathered via a patient using questionnaire and is measured via the visual analogue scale.	6 months

Collaborators and Investigators

• Sponsor: Zahedan University of Medical Sciences
• Investigators: Study Chair: eshaghali saberi, professor, professor of endodontics department

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: December 13, 2015
• First Submitted That Met QC Criteria: December 29, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Estimate): December 31, 2015
• Last Update Submitted That Met QC Criteria: December 29, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Post-operative pain; Instrumentation; Root canal preparation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 7203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED