The Effect of Using Different Single File Systems With Coronal Flaring Instruments on Postoperative Pain
The Effect of Use of Reciprocation and Rotational Single File Systems With the OneFlare Coronal Flaring Instrument on Postoperative Pain
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
Pain after root canal treatment is an important problem that affects the quality of life of patients. Common factors affecting the formation of pain after root canal treatment include insufficient root canal shaping, irrigation solution extrusion, intracanal medicament extrusion, hyperocclusion, missed canals, presence of pre-procedural pain, presence of periapical pathology, and extrusion of apical debris . It has been reported that the file systems and instrumentation technique used in root canal preparation affect apical extrusion, which is the main cause of postoperative pain . It has been reported that single-file systems introduced to the market to shorten root canal treatment time cause less postoperative pain than multi-file systems. However, there are different opinions about the effect of reciprocal and rotational file systems on postoperative pain. It has been reported that coronal flaring during root canal shaping facilitates apical access of instruments and irrigation solution. NiTi instruments generally tend to orient tissue debris coronally, coronal shaping can create a reservoir for collecting debris accumulated in the coronal portion of the root. Therefore, increasing the coronal space for debris reduces the amount of apically removed extrusion. However, single file systems do not have a coronal flaring file and canal preparation is completed with a single file. An increased amount of apical extrusion may occur due to insufficient coronal shaping during canal preparation using single-file systems. In this study, the effect of the use of coronal flaring file together with rotational and reciprocal single file systems on postoperative pain will be investigated, since there are different results about the effects of rotational and reciprocal file systems on postoperative pain, and although it has been reported that coronal flaring reduces apical extrusion, there is no study that determines the effect on postoperative pain. Thus, it is aimed to reduce the pain after root canal treatment and to have a more comfortable and painless process after the procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable postoperative-pain
Started Sep 2021
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
August 25, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedFirst Posted
Study publicly available on registry
September 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedSeptember 13, 2021
September 1, 2021
4 months
August 25, 2021
September 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analog Score Scala
Postoperative pain will be assessed with a visual analog score after endodontic treatment.
The change in the postoperative pain levels by the patient at the 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and at the end of 1 week will be compared.
Study Arms (4)
Wave One Gold
ACTIVE COMPARATORThe Wave One Gold file will be used with the VDW endodontic motor (VDW) in accordance with the manufacturer's recommendations.
One Flare and Wave One Gold file system
ACTIVE COMPARATORThe One Flare file will be used with a rotational speed of 300 rpm and 3 N/cm torque at a working length of 3 mm. After the Wave One Gold file will be used with the VDW endodontic motor (VDW) in accordance with the manufacturer's recommendations.
One Curve
ACTIVE COMPARATORThe One Curve file (Size 25) will be used in the VDW endodontic motor (VDW) in continuous rotation at 300 rpm and 2.5 Ncm torque in accordance with the manufacturer's recommendations.
One Curve with One Flare
ACTIVE COMPARATORThe One Flare file will be used with a rotational speed of 300 rpm and 3 N/cm torque at a working length of 3 mm. After the One Curve file (Size 25) will be used in the VDW endodontic motor (VDW) in continuous rotation at 300 rpm and 2.5 Ncm torque in accordance with the manufacturer's recommendations.
Interventions
During the endodontic treatment of molar teeth diagnosed with irreversible pulpitis, the effect on postoperative pain when single file systems with rotational (OneCurve) and reciprocal (WaveOne Gold) kinematics are used with and without coronal flaring instrument (OneFlare) will be compared.
Eligibility Criteria
You may qualify if:
- Healthy persons between the ages of 18 and 45 years
- Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis
You may not qualify if:
- Patients who are taken analgesic inflammatory drugs with in the last 12 hours
- Pregnancy or lactation
- Teeth with calcified canals
- Teeth with periodontal diseases
- Teeth with sensitive to percussion and palpation
- Teeth with root resorption
- Teeth with immature/open apex
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Pedulla E, Genovesi F, Rapisarda S, La Rosa GR, Grande NM, Plotino G, Adorno CG. Effects of 6 Single-File Systems on Dentinal Crack Formation. J Endod. 2017 Mar;43(3):456-461. doi: 10.1016/j.joen.2016.10.038. Epub 2017 Jan 25.
PMID: 28131416BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asist. Prof.
Study Record Dates
First Submitted
August 25, 2021
First Posted
September 13, 2021
Study Start
September 1, 2021
Primary Completion
December 30, 2021
Study Completion
July 1, 2022
Last Updated
September 13, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share