Back to resultsComparison Between M-Pro and ProTaper Next
Primary Purpose
Symptomatic Irreversible Pulpitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
M-pro files in rotating motion
ProTaper Next files in rotating motion
Sponsored by
About this trial
This is an interventional treatment trial for Symptomatic Irreversible Pulpitis
Eligibility Criteria
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.
Sites / Locations
- Faculty of Dentistry - Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
M-pro files
ProTaper Next files
Arm Description
Instrumentation using M-pro files in rotating motion
Instrumentation using ProTaper Next files in rotating motion
Outcomes
Primary Outcome Measures
Post operative pain assessed with numerical rating scale
0 (none) to 10 (severe) Numerical Pain Rating Scale up to 72 hours post-operatively
Secondary Outcome Measures
Incidence of placebo intake assessed by questioning
Amount of placebo intake up to 72 hours post-operatively
Amount of analgesic intake assessed by counting
Number of analgesic tablets up to 72 hours post-operatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03692039
Brief Title
Comparison Between M-Pro and ProTaper Next
Official Title
Comparison of Postoperative Pain After Root Canal Instrumentation Using M-Pro and ProTaper Next in Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Irreversible Pulpitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
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.
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
M-pro files
Arm Type
Experimental
Arm Description
Instrumentation using M-pro files in rotating motion
Arm Title
ProTaper Next files
Arm Type
Active Comparator
Arm Description
Instrumentation using ProTaper Next files in rotating motion
Intervention Type
Procedure
Intervention Name(s)
M-pro files in rotating motion
Intervention Description
An endodontic file that has controlled memory properties
Intervention Type
Procedure
Intervention Name(s)
ProTaper Next files in rotating motion
Intervention Description
An endodontic file that has an off center mass of rotation
Primary Outcome Measure Information:
Title
Post operative pain assessed with numerical rating scale
Description
0 (none) to 10 (severe) Numerical Pain Rating Scale up to 72 hours post-operatively
Time Frame
Up to 72 hours post-operatively
Secondary Outcome Measure Information:
Title
Incidence of placebo intake assessed by questioning
Description
Amount of placebo intake up to 72 hours post-operatively
Time Frame
Up to 72 hours post-operatively
Title
Amount of analgesic intake assessed by counting
Description
Number of analgesic tablets up to 72 hours post-operatively
Time Frame
Up to 72 hours post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Dentistry - Cairo University
City
Cairo
ZIP/Postal Code
52431
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26383696
Citation
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.
Results Reference
background
PubMed Identifier
23659098
Citation
Ruddle CJ, Machtou P, West JD. The shaping movement: fifth-generation technology. Dent Today. 2013 Apr;32(4):94, 96-9. No abstract available.
Results Reference
background
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Comparison Between M-Pro and ProTaper Next
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