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

NCT02644031 | Unknown DMC

• 1 other identifier: 7203
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Postoperative

Keywords

Instrumentation; Post-operative pain; Root canal preparation

Outcome Measures

Primary Outcomes (1)

• Information regarding post-operation pain is gathered via a patient using questionnaire and is measured via the visual analogue scale.

  6 months

Study Arms (3)

Mtwo rotary system

EXPERIMENTAL

( continuous rotation system)

Procedure: mtwo rotary system

safe-sider rotary system

EXPERIMENTAL

(reciprocating system)

Procedure: safe-sider rotary system

hand files

EXPERIMENTAL

k-files

Procedure: hand files

Interventions

mtwo rotary system PROCEDURE

post-treatment pain after using mtwo rotary system

Mtwo rotary system

safe-sider rotary system PROCEDURE

post-treatment pain after using safe-sider rotary system

safe-sider rotary system

hand files PROCEDURE

post-treatment pain after using hand files

hand files

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Zahedan University of Medical Sciences: lead

Study Sites (1)

Zahedan University of Medical Science

Zahedan, Sistan and Baloochestan, 98176699693, Iran

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• eshaghali saberi, professor

  professor of endodontics department

  STUDY CHAIR

Central Study Contacts

arezoo hooshmandi, postgraduate

CONTACT

00989177089315; hooshmandi_arezoo@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2015
• First Posted: December 31, 2015
• Study Start: December 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 31, 2015

Record last verified: 2015-12

Locations

IR (1)