Comparison Between M-Pro and ProTaper Next

NCT03692039 | Completed

• 1 other identifier: CEBD-CU-2018-09-33
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Post operative pain assessed with numerical rating scale

  0 (none) to 10 (severe) Numerical Pain Rating Scale up to 72 hours post-operatively

  Up to 72 hours post-operatively

Secondary Outcomes (2)

• Incidence of placebo intake assessed by questioning

  Up to 72 hours post-operatively

• Amount of analgesic intake assessed by counting

  Up to 72 hours post-operatively

Study Arms (2)

M-pro files

EXPERIMENTAL

Instrumentation using M-pro files in rotating motion

Procedure: M-pro files in rotating motion

ProTaper Next files

ACTIVE COMPARATOR

Instrumentation using ProTaper Next files in rotating motion

Procedure: ProTaper Next files in rotating motion

Interventions

M-pro files in rotating motion PROCEDURE

An endodontic file that has controlled memory properties

M-pro files

ProTaper Next files in rotating motion PROCEDURE

An endodontic file that has an off center mass of rotation

ProTaper Next files

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or Females.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry - Cairo University

Cairo, 52431, Egypt

Location

Related Publications (2)

• Kocak MM, Cicek E, Kocak S, Saglam BC, Furuncuoglu F. Comparison of ProTaper Next and HyFlex instruments on apical debris extrusion in curved canals. Int Endod J. 2016 Oct;49(10):996-1000. doi: 10.1111/iej.12552. Epub 2015 Oct 12.

  PMID: 26383696 BACKGROUND

• Ruddle CJ, Machtou P, West JD. The shaping movement: fifth-generation technology. Dent Today. 2013 Apr;32(4):94, 96-9. No abstract available.

  PMID: 23659098 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Endodontic department Faculty of Dentistry, Cairo University

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2018
• First Posted: October 2, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)