Postoperative Pain Associated With Three Endodontic Rotary Systems
Evaluation of Postoperative Pain After Single Visit Root Canal Treatment Associated With The Three Rotary Systems; ONE ENDO, F6 SkyTper and ProTaper Universal. (Randomized Controlled Clinical Trial)
1 other identifier
interventional
57
1 country
1
Brief Summary
Assessment of postoperative pain after root canal treatment using different 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 Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 15, 2017
CompletedFirst Posted
Study publicly available on registry
February 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 28, 2017
February 1, 2017
10 months
February 15, 2017
February 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative pain
Verbal Rating Scale (VRS) with the following scores: 0\. No pain. 1. Mild pain: any discomfort of any duration that does not require analgesics. 2. Moderate pain: pain that requires and is relieved with analgesics. 3. Severe pain: any pain that is not relieved with analgesics.
up to 72 hours after endodontic treatment
Secondary Outcomes (1)
Number of analgesics consumed
up to 72 hours after endodontic treatment
Study Arms (3)
ONE ENDO
EXPERIMENTALSingle file rotary system
F6 SKYTaper
EXPERIMENTALSingle file rotary system
ProTaper Universal
ACTIVE COMPARATORMuti-file rotary system
Interventions
Eligibility Criteria
You may qualify if:
- Systematically healthy patients,
- maxillary or mandibular premolar teeth with acute irreversible pulpitis and indicated for conventional endodontic treatment.
You may not qualify if:
- Non-vital teeth,
- teeth with apical periodontitis,
- teeth requiring endodontic retreatment,
- root resorption,
- immature / open apex,
- root canals with radiographic evidence of calcification,
- presence of more than one symptomatic tooth in the same quadrant,
- pregnancy,
- medically compromised patients,
- patients receiving medication for chronic pain,
- patients who have taken analgesics in the last 12 hours before treatment.
- teeth that have initial apical size more than 20,
- teeth that could not be treated in a single session,
- if any evidence of extrusion of root filling material noticed radiographically, patient will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Oral and Dental Medicine - Cairo University
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ola A. Hafez, MD Student
Faculty of Oral and Dental Medicine - Cairo University
- STUDY CHAIR
Alaa El-Din H. Diab, Professor
Faculty of Oral and Dental Medicine - Cairo University
- STUDY DIRECTOR
Kareem G. Abd El-Kader, Assistant Professor
Faculty of Oral and Dental Medicine - Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 15, 2017
First Posted
February 28, 2017
Study Start
October 1, 2016
Primary Completion
August 1, 2017
Study Completion
December 1, 2017
Last Updated
February 28, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share