NCT03412318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

October 6, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2020

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

January 8, 2018

Last Update Submit

February 28, 2021

Conditions

Acute Pulpitis

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain

    Post-operative pain assessed after treatment using the NRS pain scale

    2 days

Study Arms (2)

Twisted file

EXPERIMENTAL

Use of twisted file during cleaning and shaping of root canals

Device: Twisted file

Mpro

ACTIVE COMPARATOR

Use of Mpro file during cleaning and shaping of root canals

Device: Mpro

Interventions

Twisted fileDEVICE

Use of twisted file during cleaning and shaping of root canals

Twisted file
MproDEVICE

Use of Mpro during cleaning and shaping of root canals

Mpro

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmad Almorad

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 23741536BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 26, 2018

Study Start

October 6, 2018

Primary Completion

September 13, 2019

Study Completion

January 22, 2020

Last Updated

March 2, 2021

Record last verified: 2021-02

Locations

EG(1)