Impact of Cross-Sectional Design in Single-File Rotary System on Apical Debris Extrusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-40
SponsorMinia University
About this trial
Endodontic treatment aims to achieve optimal biological outcomes while minimizing patient's discomfort during and after the procedure. Postoperative pain remains a common complication and is considered a multifactorial phenomenon influenced by several factors, including preoperative pain, age, gender, systemic health, presence of apical periodontitis, instrumentation technique, type and design of endodontic instruments, and the use of intracanal medications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Teeth with mature apex
Straight root canal or mild curvature not exceeding(5-10) Schneider.
Has intact crown ( coronal structure)
Presence of one orifices and one apices, patency achieved by a #10-15 K-file to the apical foramen
Disqualifiers
Previous root canal treatment.
Internal/external resorption.
Immature root apices.
Caries/cracks/fractures on the root surface.
Trial design
Design model
Parallel
Treatments tested in this trial
AF One single-file rotary system
Procedure/Surgeryto evaluate and compare the amount of apically extruded debris using the AF One single-file rotary system, featuring a flat-sided design, and the One Curve rotary system in curved mesiobuccal canals of mandibular first molars. Additionally, this study aims to assess postoperative pain associated with both systems and to investigate the potential correlation between apical debris extrusion and postoperative pain.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: one curve fileActive comparator 1 intervention
Group B: AF Fanta flat sided file systemActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Treatment of Postoperative Pain
Pain scores will be recorded on Visual Analog Scale (VAS) using a 0 to 10 pain score basis with 0 being no pain and 10 being the worst pain. Recording will be done everyday for 7 days period.
Time frame
from 0 hours to 1 week after the procedureSponsors and contacts
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Source ClinicalTrials.gov