Back to resultsPain Intensity After Root Canal Instrumentation
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
mechanical preparation of root canal system
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- mandibular molars with acute pulpitis
Exclusion Criteria:
- badly decayed non-restorable molars
- medically compromised patients
Sites / Locations
- Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
M-pro
Hyflex
Arm Description
Outcomes
Primary Outcome Measures
Pain felt after mechanical instrumentation in the first visit
using Numeric Rating Scale (NRS) the participant will be asked to verbally rate their pain on a scale from 0 to 10, with 0 equal to no pain and 10 equal to worst possible pain
Secondary Outcome Measures
Full Information
NCT ID
NCT04216940
First Posted
December 24, 2019
Last Updated
January 2, 2020
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT04216940
Brief Title
Pain Intensity After Root Canal Instrumentation
Official Title
Assessment of Pain Intensity After Instrumentation by MPRo and Hyflex Rotatry Files in Molars With Irreversible Pulpitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 10, 2019 (Actual)
Primary Completion Date
August 28, 2019 (Actual)
Study Completion Date
August 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Assess the pain intensity in a two visit treatment of molars with irreversible pulpitis after instrumentation with two rotary systems Mpro and Hyflex files.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
M-pro
Arm Type
Experimental
Arm Title
Hyflex
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
mechanical preparation of root canal system
Intervention Description
Assess the pain intensity in a two-visit treatment of molars with irreversible pulpitis after instrumentation with two different rotary Nickle Titanium systems
Primary Outcome Measure Information:
Title
Pain felt after mechanical instrumentation in the first visit
Description
using Numeric Rating Scale (NRS) the participant will be asked to verbally rate their pain on a scale from 0 to 10, with 0 equal to no pain and 10 equal to worst possible pain
Time Frame
up to 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
mandibular molars with acute pulpitis
Exclusion Criteria:
badly decayed non-restorable molars
medically compromised patients
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Pain Intensity After Root Canal Instrumentation
We'll reach out to this number within 24 hrs