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Completed

NCT Number: NCT03692039

Comparison Between M-Pro and ProTaper Next

Comparing the postoperative pain resulting after mechanical instrumentation using M-pro files versus that resulting after using ProTaper Next rotary files in lower molar with symptomatic Irreversible pulpitis molars.

Completed

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry - Cairo University

Cairo, 52431, Egypt

About this study

Lower molars with symptomatic Irreversible pulpitis molars are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using M-pro Files or ProTaper Next files. Postoperative pain is then assessed using the Numerical Rating scale 6, 12, 24, 48 and 72 hours post-operatively . After completing the treatment, patients will instructed to take placebo if they feel pain and will be asked to provide the quantity of placebo intake until 72 hrs. In case of pain not relieved by placebo, after recording the amount of pain, the patient will be instructed to take an alternative line of pain control (Ibuprofen 400mg tablets every 6 hours). The amount and frequency of Ibuprofen intake will be recorded.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 1- Males or Females.
  • 2- Mandibular molar teeth with:
  • Pre-operative sharp pain.
  • Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).
  • Normal periapical radiographic appearance or slight widening in lamina dura using periapical index (PAI) score 1 as normal periapical structures or 2 as small changes in bone structures.

Exclusion criteria

  • Patients having significant systemic disorders.
  • Patients who are allergic to non-steroidal anti-inflammatory drugs.
  • Patients with two or more adjacent teeth requiring root canal therapy.
  • Teeth that have:
  • Necrotic pulp tissues.
  • Association with swelling or fistulous tract.
  • Acute or chronic peri-apical abscess.
  • Greater than grade I mobility.
  • Pocket depth greater than 5mm.
  • No possible restorability.
  • Previous endodontic treatment.

Treatment and study plan

M-pro files in rotating motion

Procedure

An endodontic file that has controlled memory properties

ProTaper Next files in rotating motion

Procedure

An endodontic file that has an off center mass of rotation

Primary outcomes

  1. Post operative pain assessed with numerical rating scale

    Time frame: Up to 72 hours post-operatively

    0 (none) to 10 (severe) Numerical Pain Rating Scale up to 72 hours post-operatively

Secondary outcomes

  1. Incidence of placebo intake assessed by questioning

    Time frame: Up to 72 hours post-operatively

    Amount of placebo intake up to 72 hours post-operatively

  2. Amount of analgesic intake assessed by counting

    Time frame: Up to 72 hours post-operatively

    Number of analgesic tablets up to 72 hours post-operatively

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparison of Postoperative Pain After Root Canal Instrumentation Using M-Pro and ProTaper Next in Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2018
Registry last updated
Jul 14, 2020

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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