Post-operative Pain in 2Shape Versus Protaper Next Rotary Systems
Assessment of Postoperative Pain After Using 2Shape and Protaper Next Rotary Systems in Patients With Symptomatic Pulpitis in Mandibular Molars:A Randomized Clinical Trial
1 other identifier
interventional
44
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2018
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2018
CompletedFirst Posted
Study publicly available on registry
October 3, 2018
CompletedStudy Start
First participant enrolled
December 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedOctober 3, 2018
September 1, 2018
1.7 years
September 29, 2018
October 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
3 days
Secondary Outcomes (1)
Need for / and number of analgesic tablets taken.
3 days
Other Outcomes (1)
incidence of instrument seperation during endodontic treatment (instrument seperation means instrument fracture)
1 day
Study Arms (2)
2Shape rotary system
EXPERIMENTALroot canal preparation using 2Shape rotary system in mandibular molars with symptomatic pulpitis
Protaper Next rotary system
ACTIVE COMPARATORroot canal preparation using Protaper Next rotary system comparing to 2Shape rotary system in mandibular molars with symptomatic pulpitis
Interventions
Eligibility Criteria
You may qualify if:
- \- 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.
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Double (Participant, Outcomes Assessor)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass.lecturer of endodotics
Study Record Dates
First Submitted
September 29, 2018
First Posted
October 3, 2018
Study Start
December 1, 2018
Primary Completion
August 1, 2020
Study Completion
October 1, 2020
Last Updated
October 3, 2018
Record last verified: 2018-09