Back to resultsEvaluation of the Effect of Root Canal Preparation by TF and M-Pro on Post-Operative Pain After Single Visit Endodontic Treatment
Primary Purpose
Acute Pulpitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Twisted file
Mpro
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pulpitis
Eligibility Criteria
Inclusion Criteria:
- Patients in good health (American Society of Anesthesiologists Class II or higher).
- Patients having symptomatic irreversible pulpitis in their single rooted teeth.
- Age range is between 20 and 60 years.
- Patients who can understand numerical rating scale (NRS).
- Patients able to sign informed consent.
Exclusion Criteria:
- Patients with positive percussion test.
- Patients having history of necrosis with or without apical pathosis.
- Patients have sinus tract or fistula extra oral or intraoral.
- Pregnant or mentally retarded patients.
- Teeth with grade 2 or 3 mobility.
Sites / Locations
- Ahmad Almorad
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Twisted file
Mpro
Arm Description
Use of twisted file during cleaning and shaping of root canals
Use of Mpro file during cleaning and shaping of root canals
Outcomes
Primary Outcome Measures
Post-operative pain
Post-operative pain assessed after treatment using the NRS pain scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03412318
Brief Title
Evaluation of the Effect of Root Canal Preparation by TF and M-Pro on Post-Operative Pain After Single Visit Endodontic Treatment
Official Title
Evaluation of the Effect of Root Canal Preparation by TF and M-Pro on Post-Operative Pain After Single Visit Endodontic Treatment: A Blinded Randomized Clinical Trial Therapeutic Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 6, 2018 (Actual)
Primary Completion Date
September 13, 2019 (Actual)
Study Completion Date
January 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study to comparatively evaluate the post operative pain between root canal preparation by reciprocating file (TF) and full rotation file (M-Pro) in patients with single rooted teeth with acute irreversible pulpits.
Detailed Description
Teeth with symptomatic irreversible pulpitis are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment after using Twisted files or M-pro files. The treatment is done in single visit. The postoperative pain is then assessed using the Numerical Rating Scale 6,12, 24 and 48 hours post-instrumentation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pulpitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Twisted file
Arm Type
Experimental
Arm Description
Use of twisted file during cleaning and shaping of root canals
Arm Title
Mpro
Arm Type
Active Comparator
Arm Description
Use of Mpro file during cleaning and shaping of root canals
Intervention Type
Device
Intervention Name(s)
Twisted file
Intervention Description
Use of twisted file during cleaning and shaping of root canals
Intervention Type
Device
Intervention Name(s)
Mpro
Intervention Description
Use of Mpro during cleaning and shaping of root canals
Primary Outcome Measure Information:
Title
Post-operative pain
Description
Post-operative pain assessed after treatment using the NRS pain scale
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients in good health (American Society of Anesthesiologists Class II or higher).
Patients having symptomatic irreversible pulpitis in their single rooted teeth.
Age range is between 20 and 60 years.
Patients who can understand numerical rating scale (NRS).
Patients able to sign informed consent.
Exclusion Criteria:
Patients with positive percussion test.
Patients having history of necrosis with or without apical pathosis.
Patients have sinus tract or fistula extra oral or intraoral.
Pregnant or mentally retarded patients.
Teeth with grade 2 or 3 mobility.
Facility Information:
Facility Name
Ahmad Almorad
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23741536
Citation
Gambarini G, Testarelli L, De Luca M, Milana V, Plotino G, Grande NM, Rubini AG, Al Sudani D, Sannino G. The influence of three different instrumentation techniques on the incidence of postoperative pain after endodontic treatment. Ann Stomatol (Roma). 2013 Mar 20;4(1):152-5. doi: 10.11138/ads.0152. Print 2013 Jan.
Results Reference
background
Learn more about this trial
Evaluation of the Effect of Root Canal Preparation by TF and M-Pro on Post-Operative Pain After Single Visit Endodontic Treatment
We'll reach out to this number within 24 hrs