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

NCT ID: NCT03412318

Last Updated: 2021-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-06

Study Completion Date

2020-01-22

Brief Summary

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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

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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.

Conditions

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Acute Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Twisted file

Use of twisted file during cleaning and shaping of root canals

Group Type EXPERIMENTAL

Twisted file

Intervention Type DEVICE

Use of twisted file during cleaning and shaping of root canals

Mpro

Use of Mpro file during cleaning and shaping of root canals

Group Type ACTIVE_COMPARATOR

Mpro

Intervention Type DEVICE

Use of Mpro during cleaning and shaping of root canals

Interventions

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Twisted file

Use of twisted file during cleaning and shaping of root canals

Intervention Type DEVICE

Mpro

Use of Mpro during cleaning and shaping of root canals

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Abdul Aziz Almorad

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmad Almorad

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 23741536 (View on PubMed)

Other Identifiers

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TF vs Mpro

Identifier Type: -

Identifier Source: org_study_id

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