Comparison Between M-Pro and ProTaper Next

Not Applicable

Completed

• Conditions: Symptomatic Irreversible Pulpitis
• Interventions: Procedure: M-pro files in rotating motion; Procedure: ProTaper Next files in rotating motion

• Registration Number: NCT03692039
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2018-09-29
• Study Start: 2018-10-01
• Study First Submitted QC: 2018-10-01
• Study First Posted: 2018-10-02
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M-pro files	M-pro files in rotating motion	Instrumentation using M-pro files in rotating motion
ProTaper Next files	ProTaper Next files in rotating motion	Instrumentation using ProTaper Next files in rotating motion

Primary Outcome Measures

Name	Time	Method
Post operative pain assessed with numerical rating scale	Up to 72 hours post-operatively	0 (none) to 10 (severe) Numerical Pain Rating Scale up to 72 hours post-operatively

Secondary Outcome Measures

Name	Time	Method
Amount of analgesic intake assessed by counting	Up to 72 hours post-operatively	Number of analgesic tablets up to 72 hours post-operatively
Incidence of placebo intake assessed by questioning	Up to 72 hours post-operatively	Amount of placebo intake up to 72 hours post-operatively

Trial Locations

Locations (1)

Faculty of Dentistry - Cairo University; 🇪🇬 Cairo, Egypt