Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237985
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-02
First Post:
2024-01-15
Brief Title:
Effect of Conservative Root Canal Instrumentation on the Release of Inflammatory Mediators in Root Canal Treatments
Sponsor:
Saglik Bilimleri Universitesi
Organization:
Saglik Bilimleri Universitesi
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
The below-mentioned steps will be performed in the scope of this study
1 Ethical approval has been obtained
2 The sample size calculation was performed 90 power 0597 effect size 20 patients per group
3 Patients aged 18-60 with asymptomatic irreversible pulpitis that has been confirmed by intraoral and extraoral examination and without any systemic disease will be included
4 Only mandibular first and second molar teeth that do not have complex anatomy periapical lesions deep periodontal pockets PAI2 and any fractures or cracks will be included
5 Patients with acute symptoms a history of taking analgesics 48 hours or antibiotics within 1 month prior to the visit being pregnant and lactating and having several periodontal problems will be excluded
5 Immature apexes and trauma cases will also be excluded 6 Selected patients will be informed about the study and written consent will be obtained from all patients
7 Patients will be randomly distributed into groups using a software wwwrandomizerorg Moreover patients will be blinded regarding the file system they use
8 A single operator will perform all endodontic treatments in the same clinical conditions
9 Before starting the treatment the baseline Visual Analogue Scale VAS values will be recorded
10 For baseline inflammatory mediator assessment gingival crevicular fluid samples from mesial and distal surfaces from teeth with 20 paper points for 30 seconds and paper points will be placed into Eppendorf tubes and kept at -80 until the analysis is performed
11 After the administration of the local anaesthesia teeth will be isolated with a rubber dam and access cavities will be prepared Then teeth will be allotted to one of the following file systems
Group 1 ProTaper Gold file system Sx-S1-S2-F1-F2 for mesial canals F3 for distal canal
Group 2 OneShape file system 2506 for mesial canals additional file for distal canal if needed
Group 3 TruNatomy file system 1702 2004 ve 2604 for mesial canals 3603 for distal canal
12 2 mL 25 sodium hypochlorite NaOCl will be used between files and final irrigation will be performed using 5 mL NaOCL 5 mL 17 ethylenediaminetetraacetic acid EDTA and 5 mL distilled water with 31-G side vented needle
13 After drying the canals 15 paper point will be placed inside mesial canals for 1 minute 2 mm beyond the apex Afterwards paper points will be placed into Eppendorf tubes and kept at -80 until the analysis is performed
14 Root canals will be obturated with resin-based sealer and gutta-percha 15 Permanent restoration will be done using composite 16 Patients will be recalled at 24 and 72 hours and gingival crevicular fluid samples from mesial and distal surfaces will be obtained using an above-mentioned method
17 Measurement of postoperative pain after treatment with a VAS scale at 24 48 and 72 hours will also be recorded
18 Measurement of pain mediators Substance P Prostaglandin E2 interleukin IL 6 and IL-10 will be performed with ELISA kits All samples will be analyzed in duplicate
19 Based on the readings obtained from the spectrophotometer results will be fitted to the standard curve and presented in the form of picograms per millilitre pgmL
20 Statistical analysis will be conducted
1 Ethical approval has been obtained
2 The sample size calculation was performed 90 power 0597 effect size 20 patients per group
3 Patients aged 18-60 with asymptomatic irreversible pulpitis that has been confirmed by intraoral and extraoral examination and without any systemic disease will be included
4 Only mandibular first and second molar teeth that do not have complex anatomy periapical lesions deep periodontal pockets PAI2 and any fractures or cracks will be included
5 Patients with acute symptoms a history of taking analgesics 48 hours or antibiotics within 1 month prior to the visit being pregnant and lactating and having several periodontal problems will be excluded
5 Immature apexes and trauma cases will also be excluded 6 Selected patients will be informed about the study and written consent will be obtained from all patients
7 Patients will be randomly distributed into groups using a software wwwrandomizerorg Moreover patients will be blinded regarding the file system they use
8 A single operator will perform all endodontic treatments in the same clinical conditions
9 Before starting the treatment the baseline Visual Analogue Scale VAS values will be recorded
10 For baseline inflammatory mediator assessment gingival crevicular fluid samples from mesial and distal surfaces from teeth with 20 paper points for 30 seconds and paper points will be placed into Eppendorf tubes and kept at -80 until the analysis is performed
11 After the administration of the local anaesthesia teeth will be isolated with a rubber dam and access cavities will be prepared Then teeth will be allotted to one of the following file systems
Group 1 ProTaper Gold file system Sx-S1-S2-F1-F2 for mesial canals F3 for distal canal
Group 2 OneShape file system 2506 for mesial canals additional file for distal canal if needed
Group 3 TruNatomy file system 1702 2004 ve 2604 for mesial canals 3603 for distal canal
12 2 mL 25 sodium hypochlorite NaOCl will be used between files and final irrigation will be performed using 5 mL NaOCL 5 mL 17 ethylenediaminetetraacetic acid EDTA and 5 mL distilled water with 31-G side vented needle
13 After drying the canals 15 paper point will be placed inside mesial canals for 1 minute 2 mm beyond the apex Afterwards paper points will be placed into Eppendorf tubes and kept at -80 until the analysis is performed
14 Root canals will be obturated with resin-based sealer and gutta-percha 15 Permanent restoration will be done using composite 16 Patients will be recalled at 24 and 72 hours and gingival crevicular fluid samples from mesial and distal surfaces will be obtained using an above-mentioned method
17 Measurement of postoperative pain after treatment with a VAS scale at 24 48 and 72 hours will also be recorded
18 Measurement of pain mediators Substance P Prostaglandin E2 interleukin IL 6 and IL-10 will be performed with ELISA kits All samples will be analyzed in duplicate
19 Based on the readings obtained from the spectrophotometer results will be fitted to the standard curve and presented in the form of picograms per millilitre pgmL
20 Statistical analysis will be conducted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None