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
About this trial
This is an interventional treatment trial for Endodontically Treated Teeth
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.
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
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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