Interleukin 8 And10 Levels Changes in Teeth with Necrotic Pulp and Apical Periodontitis
NCT ID: NCT06713174
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
22 participants
INTERVENTIONAL
2024-12-15
2025-01-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study Design:
Patients requiring root canal treatment at the Endodontic Clinic, Faculty of Dental Medicine for Girls, Al-Azhar University, will be recruited based on inclusion and exclusion criteria.
Inclusion Criteria:
Adults aged 18-45 years. Patients without systemic diseases. Patients diagnosed with necrotic pulp and apical periodontitis in a single-rooted tooth with a single canal.
Patients with no previous endodontic treatment or related therapeutic procedures.
Patients with normal periodontal health.
Exclusion Criteria:
Patients who decline participation. Patients on long-term anti-inflammatory medication, immunosuppressive chemotherapy, or antibiotics within the last 3 weeks.
Patients with systemic health conditions (e.g., cardiovascular diseases, diabetes mellitus, HIV, hepatitis).
Pregnant women, smokers, and those with unrestorable teeth.
Sample Collection Procedures:
1. Gingival Crevicular Fluid (GCF):
Timing: Samples will be collected at two time points:
Before initiating access into the root canal (Period 1). Before canal filling (Period 2).
Procedure:
Isolation of the area using cotton rolls. Plaque removal and gentle air drying of the tooth. Placement of sterilized paper strips in the gingival sulcus until minimal resistance is felt.
Strips will remain for one minute and will be placed on mesial or distal vestibular surfaces.
If blood contamination occurs, collection will be attempted from another site. Persistent bleeding will lead to sample exclusion.
Storage:
Strips will be placed in Eppendorf tubes with phosphate-buffered saline and frozen at -80°C until analysis.
2. Periapical Fluid:
Timing: Samples will be collected:
Just after crown access. Before root canal filling.
Procedure:
Three sequential sterile absorbent paper points will be inserted into the root canal, extending 2 mm beyond the radiographic apex.
Points will be left undisturbed for one minute. The tips (4 mm) will be cut and placed in Eppendorf tubes containing 2 mL of reduced transport fluid (RTF).
Storage:
Tubes will be stored at -80°C until analysis.
Root Canal Treatment Protocol:
Anesthesia and Isolation:
Local anesthesia with 2% lidocaine containing epinephrine 1:80,000. Rubber dam isolation.
Access and Cleaning:
Access cavity preparation using round tungsten carbide burs. Gates Glidden burs for straight-line access. Cleaning and shaping with stainless steel K-files. Irrigation with 10 mL of 2.5% sodium hypochlorite (total duration: 30 minutes). Final rinse with 2 mL of 17% EDTA for 1 minute, followed by 2 mL of sterile saline.
Sample Collection:
After initial preparation, samples from periapical fluid will be collected as described.
Temporary filling material will be used to seal the access cavity.
Completion of Treatment:
Seven days later, temporary fillings will be removed, and second samples of GCF and periapical fluid will be collected.
The root canals will be filled using gutta-percha and epoxy resin sealer via lateral compaction.
Composite resin will seal the access cavity.
Storage and Analysis:
All samples will be preserved at -80°C until biomarker analysis is performed. The study focuses on evaluating changes in key biomarkers (e.g., interleukins) associated with inflammation and healing during treatment.
This description ensures clarity, technical detail, and adherence to ethical and procedural standards, avoiding duplication of information from other sections
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
assessment of interleukin 8,10 pre and post
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.
Assessment of Interleukin 8 and 10 Level Changes Before and During Root Canal Treatment for Necrotic Pulp with Apical Periodontitis
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Assessment of Interleukin 8 and 10 Level Changes Before and During Root Canal Treatment for Necrotic Pulp with Apical Periodontitis
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
1\. 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.
\-
Exclusion Criteria
2. Patients who have been on long-term anti-inflammatory medication,received immunosuppressive chemotherapy or taken antibiotics within the last 3 weeks.
3. Patients with systemic health conditions such as cardiovascular and respiratory diseases, diabetes mellitus, HIV infection, or hepatitis.
4. Unrestorable teeth, pregnant women, and smokers will also be excluded from the study
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Faculty of Dental Medicine for Girls
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Esraa Mohamed elsagheer Hassan
Dentist at ministry of health
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ENDOD-101-1-b
Identifier Type: -
Identifier Source: org_study_id