Irreversible Pulpitis Clinical Trial
Official title:
Evaluation of the Effect of Conservative Root Canal Instrumentation on the Release of Inflammatory Mediators in Root Canal Treatments: a Randomized Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Saglik Bilimleri Universitesi |
Bicakci 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. — View Citation
Canakci 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: — View Citation
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 — View Citation
Nunez 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. — View Citation
Shin 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of Substance P | Measurement of Substance P | Before root canal treatment (Day 0), at 24 hours, and at 72 hours | |
Primary | Measurement of Prostaglandin E2 | Measurement of Prostaglandin E2 | Before root canal treatment (Day 0), at 24 hours, and at 72 hours | |
Primary | Release of inflammatory mediators | Measurement of Prostaglandin IL-6 | Before root canal treatment (Day 0), at 24 hours, and at 72 hours | |
Primary | Measurement of IL-10 | Measurement of IL-10 | Before root canal treatment (Day 0), at 24 hours, and at 72 hours | |
Secondary | Postoperative pain assessment using visual analog scale | Postoperative pain assessment using visual analog scale | Before root canal treatment (Day 0), at 24 hours, and at 72 hours |
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