Effect of Using Different Concentrations of NaOCI on IL-8 Level

NCT05277246 | Unknown

• 1 other identifier: 11/15.12.2021
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective is to compare various concentrations of NAOCL during Root canal treatment and their effect on IL-8 at the gingival crevicular fluid. Despite the current advancement of beneficial endodontic diagnostic methods, such as pulp sensitivity tests and periapical radiographs, clinical outcomes do not always correspond with the arrangement of the histological condition of the pulp. At this point, the need for other ways to help diagnose pathological pulpal disease has arisen. This situation has influenced researchers to use molecular evaluation as an alternative route in endodontic diagnosis. Biomarkers, functional at the cellular and molecular level, are crucial elements within the pathological process. Detection of molecular markers is considered an ancillary method for diagnosing the pathological condition of the pulp tissue.An increase in inflammatory cells in the carious or traumatized dentinal pulp complex has been reported. In the presence of bacteria, immune cells produce interleukin-6 (IL6), interleukin-8 (CXCL8), and tumor necrosis factor-alpha (TNF) in the pulp. Interleukin-8 is frequently expressed in endothelial cells of inflamed pulp and rarely in the normal pulp. Karapanou et al. (2008) revealed that interleukin-8 was more greatly released in teeth with irreversible pulpitis than in the control group in a research in which gingival crevicular fluid with acute pulpitis was analyzed. the pulp tissue and gingival crevicular fluid of teeth with symptomatic irreversible pulpitis were dramatically augmented by these indicators compared with healthy teeth. Furthermore, they concluded that the levels of NKA, SP, IL8, and MMP8 in the gingival crevicular fluid decreased one week after endodontic treatment of teeth with pulpitis. Subsequently, it has been reported that patients with symptomatic irreversible pulpitis with high initial pain scores have higher levels of SP, IL8, and MMP8 in the pulp tissue samples than those with low pain scores.It is recommended to use NaOCl concentration between 0.5% and 5.25% as an irrigation solution in root canal treatment (6). The effectiveness of NaOCl increases with increasing concentration, but its toxicity is known to be proportional to concentration. Therefore, there is no consensus on the optimal concentration of NaOCL. When articles were reviewed, it was found that inflammation of the pulp and biomarker levels are correlated. For this reason, we believe that whether or not NaOCl solution at various concentrations causes inflammation can be analyzed by the level of IL-8. Upon review of the literature, it was found that no studies investigated the influence of NaOCl solution on biomarkers in the gingival crevicular fluid. The research described below contributes to the literature on the optimal concentration of NaOCl to use.

Conditions

Irreversible Pulpitis

Keywords

Gingival cervicular fluidi; IL-8

Outcome Measures

Primary Outcomes (1)

• IL-8 Level

  Concentration of IL-8 in GCF

  6 months

Study Arms (3)

1% NaOCIL

ACTIVE COMPARATOR

2 ml of 1% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length.

Other: Irrigant concentration; Drug: NaOCI

2.5% NaOCI

ACTIVE COMPARATOR

2 ml of 2.5% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length.

Other: Irrigant concentration; Drug: NaOCI

5.25% NaOCI

ACTIVE COMPARATOR

2 ml of 5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length.

Other: Irrigant concentration; Drug: NaOCI

Interventions

Irrigant concentration OTHER

The success of endodontic treatment is directly related to infection control. In successful endodontic treatment, it is necessary to perform an ideal irrigation both in order to gain a better understanding of the complex anatomical structure of the root canals and to increase the efficiency of the instruments and methods used during the canal preparation. Sodium hypochlorite (NaOCl) solution is the standard irrigation agent for cleaning and disinfection of root canal. In this study, the effect of NaOCI on level of IL-8 different concentration will be evaluated.

1% NaOCIL; 2.5% NaOCI; 5.25% NaOCI

NaOCI DRUG

NaOCI

1% NaOCIL; 2.5% NaOCI; 5.25% NaOCI

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 periodontal diseases
• Teeth with sensitive to percussion and palpation
• Teeth with root resorption
• Teeth with immature/open apex

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Central Study Contacts

Hacer Aydınyurt, PhD

CONTACT

905304589710; hacersahin@gmail.com

Murat Tunca, PhD

CONTACT

905337141230; dtmurattunca@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asis.Prof.

Model Details: Group 1; 2 ml of 1% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length. Group 2: 2 ml of 2.5% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length. Group 3; 2 ml of 5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length.

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 14, 2022
• Study Start: March 20, 2022
• Primary Completion: June 20, 2022
• Study Completion: July 20, 2022
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share