Post-operative Pain in 2Shape Versus Protaper Next Rotary Systems
Primary Purpose
Pulpitis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
2Shape rotary system
Sponsored by
About this trial
This is an interventional treatment trial for Pulpitis focused on measuring mandibular molars
Eligibility Criteria
Inclusion Criteria:
- - Medically free patients.
- Patients with symptomatic pulpitis in one of their mandibular molars.
- Patient's age ranges between 22 to 45 years with no sex predilection.
- Patients who can understand Numerical Analogue Scales (NRS).
- Patients able to sign informed consent.
Exclusion Criteria:
- - Patients having a systemic disorder.
- Presence of periapical lesion.
- Pregnant females.
- Patients who had taken analgesics during the last 12 hours preoperatively.
- Patients having active pain in more than one tooth.
- Non- educated patients.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
2Shape rotary system
Protaper Next rotary system
Arm Description
root canal preparation using 2Shape rotary system in mandibular molars with symptomatic pulpitis
root canal preparation using Protaper Next rotary system comparing to 2Shape rotary system in mandibular molars with symptomatic pulpitis
Outcomes
Primary Outcome Measures
intensity of postoperative pain assessed by numerical rating scale Immediately after the end of treatment, and at 6, 12, 24, 48, and 72 hours. post-operative pain
using numerical rating scale ranges between (0-10) where 0 indicates no pain while 10 indicates maximum pain degree
Secondary Outcome Measures
Need for / and number of analgesic tablets taken.
incidence and number of analgesic tablets will be recorded
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03694743
Brief Title
Post-operative Pain in 2Shape Versus Protaper Next Rotary Systems
Official Title
Assessment of Postoperative Pain After Using 2Shape and Protaper Next Rotary Systems in Patients With Symptomatic Pulpitis in Mandibular Molars:A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
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
5. Study Description
Brief Summary
Pain after endodontic treatment is considered the most disturbing problem facing both the patient and the dentist especially in cases of symptomatic pulpitis as the patient is expecting to relief the pain that already exists.Therefore, this study aims to find a solution for the post-operative pain felt by the patient with symptomatic pulpitis in mandibular molars through comparing post-operative pain following use of 2Shape and Protaper Next rotary systems.
Detailed Description
Root canal preparation is the most important step in endodontic treatment. For successful treatment, pulp tissue, dentin debris and microorganisms should be completely eradicated from the root canal system.However, it has been reported that all the instrumentation techniques (manual or mechanical) cause debris extrusion into the periradicular tissue resulting in periapical inflammation that causes post-operative pain and flare up.
Instrumentation technique and instrument design were found to be related to the amount of debris extruded which is the main cause of post-operative pain. It has been reported that rotary NiTi systems cause less debris extrusion than manual instrumentation.
Within NiTi systems, instrument design, taper and tip size were found to affect debris extrusion. Therefore, new innovations in the instrument designs are introduced in order to reduce post-operative pain and flare up incidence.
Therefore, this study is established to compare the effect of 2 different rotary systems on postoperative pain in patients with symptomatic pulpitis.
The aim of the present study is to assess the effect of rotary instrumentation using Protaper Next rotary system versus 2Shape rotary system on postoperative pain and the number of analgesics taken by the patient following single visit root canal treatment in mandibular molars with symptomatic pulpitis.
Primary objective:
Comparing the intensity of post-operative pain using Numerical Rating Scale (NRS) immediately after root canal treatment and post-appointment at 6, 12, 24, 48 and 72hours.
Secondary objectives:
The need for / and number of analgesic tablets taken within 3 days after end of endodontic treatment.
Instrument separation during instrumentation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis
Keywords
mandibular molars
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Double (Participant, Outcomes Assessor)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2Shape rotary system
Arm Type
Experimental
Arm Description
root canal preparation using 2Shape rotary system in mandibular molars with symptomatic pulpitis
Arm Title
Protaper Next rotary system
Arm Type
Active Comparator
Arm Description
root canal preparation using Protaper Next rotary system comparing to 2Shape rotary system in mandibular molars with symptomatic pulpitis
Intervention Type
Device
Intervention Name(s)
2Shape rotary system
Intervention Description
root canal preparation
Primary Outcome Measure Information:
Title
intensity of postoperative pain assessed by numerical rating scale Immediately after the end of treatment, and at 6, 12, 24, 48, and 72 hours. post-operative pain
Description
using numerical rating scale ranges between (0-10) where 0 indicates no pain while 10 indicates maximum pain degree
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Need for / and number of analgesic tablets taken.
Description
incidence and number of analgesic tablets will be recorded
Time Frame
3 days
Other Pre-specified Outcome Measures:
Title
incidence of instrument seperation during endodontic treatment (instrument seperation means instrument fracture)
Description
incidence will be recorded
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Medically free patients.
Patients with symptomatic pulpitis in one of their mandibular molars.
Patient's age ranges between 22 to 45 years with no sex predilection.
Patients who can understand Numerical Analogue Scales (NRS).
Patients able to sign informed consent.
Exclusion Criteria:
- Patients having a systemic disorder.
Presence of periapical lesion.
Pregnant females.
Patients who had taken analgesics during the last 12 hours preoperatively.
Patients having active pain in more than one tooth.
Non- educated patients.
12. IPD Sharing Statement
Learn more about this trial
Post-operative Pain in 2Shape Versus Protaper Next Rotary Systems
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