Effect of Conservative Root Canal Instrumentation on the Release of Inflammatory Mediators in Root Canal Treatments
Evaluation of the Effect of Conservative Root Canal Instrumentation on the Release of Inflammatory Mediators in Root Canal Treatments: a Randomized Clinical Trial
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The goal of this clinical trial is to evaluate the expression of inflammatory mediators in the crevicular fluid and periodontal ligament after one-visit root canal treatment of mandibular molars of patients with asymptomatic irreversible pulpitis using 3 different file systems. The main question it aims to answer is: Does conservative root canal preparation cause decreased expression of inflammatory mediators compared to conventional root canal preparation? In this context, patients will be divided into 3 groups based on the file systems as follows: ProTaper Gold, OneShape, and TruNatomy up to apical size #25. Both inflammatory mediator expression and postoperative VAS values will be compared.
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 Feb 2024
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
January 15, 2024
CompletedFirst Posted
Study publicly available on registry
February 2, 2024
CompletedStudy Start
First participant enrolled
February 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedFebruary 2, 2024
January 1, 2024
2 months
January 15, 2024
January 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Measurement of Substance P
Measurement of Substance P
Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of Prostaglandin E2
Measurement of Prostaglandin E2
Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Release of inflammatory mediators
Measurement of Prostaglandin IL-6
Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of IL-10
Measurement of IL-10
Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Secondary Outcomes (1)
Postoperative pain assessment using visual analog scale
Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Study Arms (3)
ProTaper Gold file system
EXPERIMENTALSx-S1-S2-F1-F2 files for mesial canals and F3 file for distal canal with 350 rpm speed and 2 Ncm torque will be used via an endodontic motor.
OneShape file system
EXPERIMENTAL25/.06 file for mesial canals with 350 rpm and 4 Ncm torque will be used via an endodontic motor.
TruNatomy file system
EXPERIMENTAL17/.02, 20/.04 ve 26/.04 files for mesial canals and 36/.03 file for distal canal with 500 rpm speed and 1.5 Ncm torque will be used via an endodontic motor.
Interventions
According to the manufacturers ' instructions, root canal treatments will be conducted with the ProTaper Gold rotary file system up to F2 for mesial canals.
According to the manufacturers ' instructions, root canal treatments will be conducted with the OneShape rotary file system up to 25/.06 for mesial canals.
According to the manufacturers ' instructions, root canal treatments will be conducted with the TruNatomy rotary file system up to 26/.04 for mesial canals.
Eligibility Criteria
You may qualify if:
- Patients aged 18-60
- Patients with asymptomatic irreversible pulpitis that has been confirmed by intraoral and extraoral examination
- Patients with pain pain between 0 and 3 on the VAS scale
- Patients without any systemic disease
- Mandibular first and second molar teeth without complex root canal anatomy, calcifications, periapical lesions, deep periodontal pockets (PAI\<2), and any fractures or cracks
You may not qualify if:
- Patients with acute symptoms
- Patients who have a history of taking analgesics 48 h or antibiotics within 1 month prior to the visit
- Patients who are being pregnant and lactating
- Patients with several periodontal problems
- Patients with systemic disease
- Teeth with immature root apexes
- Trauma cases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
Kasikci S, Turker SA, Guven B. Effect of different retreatment files using different kinematics on the release of inflammatory mediators in root canal retreatment of single-rooted teeth: a randomized clinical trial. Clin Oral Investig. 2023 Jun;27(6):3189-3196. doi: 10.1007/s00784-023-04930-6. Epub 2023 Mar 1.
PMID: 36856848RESULTBicakci H, Capar ID, Genc S, Ihtiyar A, Sutcu R. Influence of Rotary Instrumentation with Continuous Irrigation on Pain and Neuropeptide Release Levels: A Randomized Clinical Trial. J Endod. 2016 Nov;42(11):1613-1619. doi: 10.1016/j.joen.2016.08.010.
PMID: 27788771RESULTNunez N, Erdogan O, Casey SM, Hernandez R, Tan S, Gibbs JL. Elevated Cytokine Levels in Gingival Crevicular Fluid of Teeth with Apical Periodontitis. J Endod. 2023 Jun;49(6):657-663. doi: 10.1016/j.joen.2023.03.010. Epub 2023 Mar 24.
PMID: 36965768RESULTShin SJ, Lee W, Lee JI, Baek SH, Kum KY, Shon WJ, Bae KS. Matrix metalloproteinase-8 and substance P levels in gingival crevicular fluid during endodontic treatment of painful, nonvital teeth. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Oct;112(4):548-54. doi: 10.1016/j.tripleo.2011.04.026. Epub 2011 Aug 10.
PMID: 21831678RESULTCanakci BC, Er O, Genc Sen O, Sut N. The effect of two rotary and two reciprocating NiTi systems on postoperative pain after root canal retreatment on single-rooted incisor teeth: A randomized controlled trial. Int Endod J. 2021 Nov;54(11):2016-2024. doi: 10.1111/iej.13609. Epub 2021 Aug 29.
PMID: 34383324RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Serpil Karaoğlanoğlu, Professor
Saglik Bilimleri Universitesi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Patients who will be treated and the assessor who will perform the analysis in lab will be blinded regarding which file is used for each patient.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 15, 2024
First Posted
February 2, 2024
Study Start
February 15, 2024
Primary Completion
April 15, 2024
Study Completion
April 30, 2024
Last Updated
February 2, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share
Within the scope of the necessity of protecting the individual information of the patients, it is considered that the recorded data will not be shared.