Comparative Evaluation of Different File Systems in Postoperative Pain
1 other identifier
observational
60
1 country
1
Brief Summary
Postoperative pain is a frequent complication associated with root canal treatment. The apical extrusion of irrigant and debris, including bacteria and necrotic tissue, may lead to postoperative pain, periapical inflammation, and flare-ups. The instrumentation technique and the file design may affect the amount of debris extrusion. The aim of this study was to evaluate the influence of instrumentation techniques on the incidence and intensity of postoperative pain after single-visit root canal treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2017
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2018
CompletedFirst Submitted
Initial submission to the registry
October 11, 2018
CompletedFirst Posted
Study publicly available on registry
October 17, 2018
CompletedDecember 20, 2018
December 1, 2018
1.3 years
October 11, 2018
December 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Post operative pain
Postoperative pain which occurs after root canal instrumentation and measured with a commonly used scale named 'four-point pain intensity scale' for pain intensity. Patients were instructed postoperatively to express their pain according to the staed scale ranging between no pain and severe pain. The scale consists of 4 scores ranging between 1-4. The pain categories were as follows; 1. no pain; 2. mild pain (slight discomfort, no need for treatment); 3. moderate pain (pain relieved by medication); 4. severe pain (pain and/or swelling not relieved by simple analgesic medication and unscheduled visit required). For patients having no pain score 1, for patients having slight pain in case of no medication score 2 , and score 3 in case of any requirement of medication due to moderate pain, and score 4 for patients having severe pain with the requirement of an unscheduled visit were accepted. The higher values represent more pain intensity.
2 days
Study Arms (2)
Group 1
Root canal treatments will be completed by ProTaper Next instruments with rotational motion
Group 2
Root canal treatments will be completed TF Adaptive instruments with adaptive motion.
Interventions
Eligibility Criteria
patients referred to dental clinic for endodontic treatment
You may qualify if:
- having root canal treatment indication
- single root canal
You may not qualify if:
- previously treated tooth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bülent Ecevit University, Faculty of Dentistry
Zonguldak, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
October 11, 2018
First Posted
October 17, 2018
Study Start
June 1, 2017
Primary Completion
September 10, 2018
Study Completion
October 5, 2018
Last Updated
December 20, 2018
Record last verified: 2018-12