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Completed

NCT Number: NCT03412318

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

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.

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Key information

Conditions

Acute Pulpitis

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmad Almorad

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Twisted file

Device

Use of twisted file during cleaning and shaping of root canals

Mpro

Device

Use of Mpro during cleaning and shaping of root canals

Primary outcomes

  1. Post-operative pain

    Time frame: 2 days

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 26, 2018
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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