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

Primary Purpose

Endodontically Treated Teeth

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
reciproc
race rotary
Sponsored by
Sajad Ansari Fard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontically Treated Teeth

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dental clinic of BandarAbbas faculty of dentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

race

reciproc

Arm Description

race rotation protocol

reciprocal endodontic treatment group

Outcomes

Primary Outcome Measures

change of the Visual analogue scale
change of the vas evaluation

Secondary Outcome Measures

Full Information

First Posted
February 4, 2018
Last Updated
April 4, 2018
Sponsor
Sajad Ansari Fard
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1. Study Identification

Unique Protocol Identification Number
NCT03488836
Brief Title
Evaluation the Post Operative Pain of Endodontic Treated Molar Tooth With Race and Reciprocal Systems Among Bandarabbas Patients in 2017
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2018 (Anticipated)
Primary Completion Date
July 2, 2018 (Anticipated)
Study Completion Date
November 2, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sajad Ansari Fard

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
race
Arm Type
Active Comparator
Arm Description
race rotation protocol
Arm Title
reciproc
Arm Type
Active Comparator
Arm Description
reciprocal endodontic treatment group
Intervention Type
Procedure
Intervention Name(s)
reciproc
Intervention Description
rotary reciprocating protocol
Intervention Type
Procedure
Intervention Name(s)
race rotary
Intervention Description
race rotary group protocol
Primary Outcome Measure Information:
Title
change of the Visual analogue scale
Description
change of the vas evaluation
Time Frame
6-12-18-24-48-72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Dental clinic of BandarAbbas faculty of dentistry
City
Bandar Abbas
State/Province
Hormozgan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdol mehdi araghizade, Md, PhD
Phone
07633337192
Ext
076
Email
abdolmehdi.araghizadeh@hums.ac.ir
Phone
07633337192

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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