Interleukin 8 and10 Levels Changes in Teeth With Necrotic Pulp and Apical Periodontitis

NCT06713174 | Completed

• 1 other identifier: ENDOD-101-1-b
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate changes in interleukin 8 (IL-8) and interleukin 10 (IL-10) levels in gingival crevicular fluid (GCF) and periapical fluid during root canal treatment in patients with necrotic pulp and apical periodontitis. The main question it aims to answer is: How do IL-8 and IL-10 levels in GCF and periapical fluid change over the course of treatment? Participants will: Provide samples of GCF and periapical fluid at two different time points during their root canal treatment. Undergo treatment based on standard clinical protocols for necrotic pulp and apical periodontitis.

Conditions

Pulp and Periapical Tissue Disease; Patients With Pulp Necrosis and Apical Periodontitis

Keywords

interleukin 8; interleukin 10; necrotic pulp; periodontitis

Outcome Measures

Primary Outcomes (1)

• To assess changes in IL-8 and IL-10 levels in GCF and periapical fluid and evaluate if they are equivalent and can be used as markers of the inflammatory response before and during RCT.

  The study will collect data at various time points, including baseline (pre-RCT) and during RCT.

Study Arms (1)

assessment of interleukin 8,10 pre and post

OTHER

Gingival crevicular fluid sampling Gingival crevicular fluid (GCF) will be collected at two different time points. The collection periods will be defined as follows: before initiating access into the root canal (period 1), and before canal filling (period 2). Periapical Fluid sample: Periapical fluid samples will be collected at two different time points. The collection periods will be defined as follows: just after crown access and before root canal filling , by introducing 3 sequential sterile absorbent paper points of a size compatible with the root canal. These paper points will be introduced into the canal until they extend 2 mm beyond the radiographically determined apex.

Diagnostic Test: Assessment of Interleukin 8 and 10 Level Changes Before and During Root Canal Treatment for Necrotic Pulp with Apical Periodontitis

Interventions

Assessment of Interleukin 8 and 10 Level Changes Before and During Root Canal Treatment for Necrotic Pulp with Apical Periodontitis DIAGNOSTIC_TEST

This study will be performed to investigate interleukin-8 (IL-8) and interleukin-10 (IL-10) level changes in gingival crevicular fluid (GCF) and periapical fluid before and during root canal treatment (RCT) in patients with necrotic pulp and apical periodontitis. The null hypothesis tested will be There is no significant difference in (IL-8) and (IL-10) levels in gingival crevicular fluid (GCF) and periapical before and during root canal treatment (RCT) for necrotic pulp with apical periodontitis.

assessment of interleukin 8,10 pre and post

Eligibility Criteria

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

You may qualify if:

• Adult patients aged between 18 and 45 years.
• Patients without any systemic diseases.
• Patients diagnosed with pulp necrosis and apical periodontitis of a single root with a single canal who are seeking endodontic treatment.
• Patients who have not previously received endodontic treatment or any related therapeutic procedures.
• Patients with normal periodontal health.
• \. Adult patients aged between 18 and 45 years. 2. Patients without any systemic diseases. 3. Patients diagnosed with pulp necrosis and apical periodontitis of a single root with a single canal who are seeking endodontic treatment. 4. Patients who have not previously received endodontic treatment or any related therapeutic procedures. 5. Patients with normal periodontal health.

You may not qualify if:

• Patients who refuse to participate in the study.
• Patients who have been on long-term anti-inflammatory medication,received immunosuppressive chemotherapy or taken antibiotics within the last 3 weeks.
• Patients with systemic health conditions such as cardiovascular and respiratory diseases, diabetes mellitus, HIV infection, or hepatitis.
• Unrestorable teeth, pregnant women, and smokers will also be excluded from the study

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (1)

Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, Egypt

Location

MeSH Terms

Conditions

Periapical Periodontitis; Dental Pulp Necrosis; Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Dental Pulp Diseases; Tooth Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist at ministry of health

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 3, 2024
• Study Start: December 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: March 30, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)