Comparison Between M-Pro and ProTaper Next

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Symptomatic Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blocks of 4 are generated on a Microsoft Excel sheet where the intervention and control are denoted A \& B and randomly distributed. The table is kept with the assistant supervisor.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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Study Groups

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M-pro files

Instrumentation using M-pro files in rotating motion

Group Type EXPERIMENTAL

M-pro files in rotating motion

Intervention Type PROCEDURE

An endodontic file that has controlled memory properties

ProTaper Next files

Instrumentation using ProTaper Next files in rotating motion

Group Type ACTIVE_COMPARATOR

ProTaper Next files in rotating motion

Intervention Type PROCEDURE

An endodontic file that has an off center mass of rotation

Interventions

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M-pro files in rotating motion

An endodontic file that has controlled memory properties

Intervention Type PROCEDURE

ProTaper Next files in rotating motion

An endodontic file that has an off center mass of rotation

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes