Evaluation the Post Operative Pain of Endodontic Treated Molar Tooth With Race and Reciprocal Systems Among Bandarabbas Patients in 2017

Evaluation the Post Operative Pain of Endodontic Treated Molar Tooth With Race and Reciprocal Systems Among Bandarabbas Patients in 2017: A Double Blind Randomized Controlled Trial

extrusion of infected dentin into the periapical tissue has been suggested as a major source of pain after endodontic treatment. Although debris extrusion is an inevitable finding even when instrumentation is limited to the confines of the canal, different armamentarium seem to be associated with different amounts of debris extrusion. Studies on the effect of various rotary files on post-endodontic pain are very few and have yielded conflicting results with some favoring full-sequence and others leaning towards reciprocal rotary systems. This study aims at assessing the intensity of post-endodontic pain following two different rotary systems, Reciproc and race.

Methods: in this single-blind, parallel-grouped randomized clinical trial a total of 150 otherwise healthy patients aged between 20 to 50 years old with a pulpal status of irreversible pulpitis for one tooth in the upper or lower molar region were analyzed. A clinician performed the endodontic treatment in two groups, a group instrumented using race and a third group with instrumentation performed using Reciproc rotary systems.

Study Overview

• Status: Unknown
• Conditions: Endodontically Treated Teeth
• Intervention / Treatment: Procedure: reciproc; Procedure: race rotary

• Study Type: Interventional
• Enrollment (Anticipated): 132
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Hormozgan
    • Bandar Abbas, Hormozgan, Iran, Islamic Republic of
      • Recruiting
      • Dental clinic of BandarAbbas faculty of dentistry
      • Contact: Abdol mehdi araghizade, Md, PhD; Phone Number: 076 07633337192; Email: abdolmehdi.araghizadeh@hums.ac.ir
      • Contact: Phone Number: 07633337192

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:

• Inclusion criteria: the otherwise healthy patients were aged between 20 to 50 years old with a pulpal status of irreversible pulpitis for one tooth in the upper or lower molar region.

Exclusion Criteria:

• Exclusion criteria: previous endodontic treatment; a history of drug intake including corticosteroids; opioids and NSAIDs in the previous 12 hours; pregnancy; complicated anatomy (curves greater than 25 degrees); calcifications; internal & external resorption; open apices; periodontal disease; swelling & abscess; presence of periapical lesions; sensitivity to percussion and lack of occlusal contact.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: race; race rotation protocol	Procedure: reciproc; rotary reciprocating protocol
ACTIVE_COMPARATOR: reciproc; reciprocal endodontic treatment group	Procedure: race rotary; race rotary group protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of the Visual analogue scale	change of the vas evaluation	6-12-18-24-48-72 hours

Collaborators and Investigators

• Sponsor: Sajad Ansari Fard

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 2, 2018
• Primary Completion (ANTICIPATED): July 2, 2018
• Study Completion (ANTICIPATED): November 2, 2018

Study Registration Dates

• First Submitted: February 4, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (ACTUAL): April 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Tooth, Nonvital
• Other Study ID Numbers: 911150105

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No