- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04216940
Pain Intensity After Root Canal Instrumentation
January 2, 2020 updated by: Maram Obeid, Ain Shams University
Assessment of Pain Intensity After Instrumentation by MPRo and Hyflex Rotatry Files in Molars With Irreversible Pulpitis
Assess the pain intensity in a two visit treatment of molars with irreversible pulpitis after instrumentation with two rotary systems Mpro and Hyflex files.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- ain shams University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- mandibular molars with acute pulpitis
Exclusion Criteria:
- badly decayed non-restorable molars
- medically compromised patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: M-pro
|
Assess the pain intensity in a two-visit treatment of molars with irreversible pulpitis after instrumentation with two different rotary Nickle Titanium systems
|
Experimental: Hyflex
|
Assess the pain intensity in a two-visit treatment of molars with irreversible pulpitis after instrumentation with two different rotary Nickle Titanium systems
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain felt after mechanical instrumentation in the first visit
Time Frame: up to 72 hours
|
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
|
up to 72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2019
Primary Completion (Actual)
August 28, 2019
Study Completion (Actual)
August 28, 2019
Study Registration Dates
First Submitted
December 24, 2019
First Submitted That Met QC Criteria
January 2, 2020
First Posted (Actual)
January 3, 2020
Study Record Updates
Last Update Posted (Actual)
January 3, 2020
Last Update Submitted That Met QC Criteria
January 2, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- pain intensity
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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