Comparison Between M-Pro and ProTaper Next

Cairo University (CU)

Status: Completed

Conditions: Symptomatic Irreversible Pulpitis

Treatments: Procedure: M-pro files in rotating motion; Procedure: ProTaper Next files in rotating motion

Study type: Interventional

Funder types: Other

Identifiers

NCT03692039

CEBD-CU-2018-09-33

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

M-pro files

Experimental group

Description:

Instrumentation using M-pro files in rotating motion

Treatment:

Procedure: M-pro files in rotating motion

ProTaper Next files

Active Comparator group

Description:

Instrumentation using ProTaper Next files in rotating motion

Treatment:

Procedure: ProTaper Next files in rotating motion