Evaluation of the Effect of Root Canal Preparation by TF and M-Pro on Post-Operative Pain After Single Visit Endodontic Treatment

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.

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.

Study Overview

• Status: Completed
• Conditions: Acute Pulpitis
• Intervention / Treatment: Device: Twisted file; Device: Mpro

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ahmad Almorad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Twisted file; Use of twisted file during cleaning and shaping of root canals	Device: Twisted file; Use of twisted file during cleaning and shaping of root canals
Active Comparator: Mpro; Use of Mpro file during cleaning and shaping of root canals	Device: Mpro; Use of Mpro during cleaning and shaping of root canals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain	Post-operative pain assessed after treatment using the NRS pain scale	2 days

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2018
• Primary Completion (Actual): September 13, 2019
• Study Completion (Actual): January 22, 2020

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 20, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: February 28, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Pulpitis
• Other Study ID Numbers: TF vs Mpro

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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