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Clinical Trials/NCT03692039
NCT03692039
Completed
Not Applicable

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

Cairo University1 site in 1 country50 target enrollmentOctober 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Symptomatic Irreversible Pulpitis
Sponsor
Cairo University
Enrollment
50
Locations
1
Primary Endpoint
Post operative pain assessed with numerical rating scale
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
October 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohammed Essam Othman Ibrahim

Resident at Endodontic department Faculty of Dentistry, Cairo University

Cairo University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Amount of analgesic intake assessed by counting(Up to 72 hours post-operatively)
  • Incidence of placebo intake assessed by questioning(Up to 72 hours post-operatively)

Study Sites (1)

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