Comparison Between M-Pro and ProTaper Next

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Mohammed Essam Othman Ibrahim，Cairo University

Tracking Information

First Submitted Date ^ICMJE

September 29, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

October 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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
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

Descriptive Information

Brief Title ^ICMJE

Comparison Between M-Pro and ProTaper Next

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Interventional
Masking Description:After the operator find an eligible participant, a phone call is made to the assistant supervisor to confirm the patient eligibility then to assign the participant to either group according to the generated random sequence.
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Procedure: M-pro files in rotating motion
An endodontic file that has controlled memory properties
Procedure: ProTaper Next files in rotating motion
An endodontic file that has an off center mass of rotation

Study Arms

Experimental: M-pro files
Instrumentation using M-pro files in rotating motion
Active Comparator: ProTaper Next files
Instrumentation using ProTaper Next files in rotating motion

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 2019

Estimated Primary Completion Date

October 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Age between 15-55 years old. - 2- Males or Females. - 3- 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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

15 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Egypt

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Mohammed Essam Othman Ibrahim，Cairo University

Study Sponsor ^ICMJE

Cairo University

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Cairo University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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