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Expression of IL-8 Before and After Root Canal Treatment in Patients With Symptomatic Apical Periodontitis

Primary Purpose

Apical Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Root canal instrumentation, 2.5% NaOCl irrigation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Apical Periodontitis focused on measuring interleukin 8, apical periodontitis

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Medically free patients Single canaled teeth diagnosed clinically with symptomatic apical periodontitis. Radiographic widening in the periodontal membrane space. Presence of pain on percussion. Patients' acceptance to participate in the trial. Exclusion Criteria: Medically compromised patients. Pregnant women: Avoid radiation exposure, anesthesia, and medication. If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively. Teeth that shows association with acute periapical abscess or swelling: Need special treatment steps which could involve additional visits with incision and drainage. Presence of periodontal disease Non restorability Immature teeth Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Sites / Locations

  • Faculty of Dentistry, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Vital teeth

Non-vital teeth

Arm Description

root canal instrumentation sodium hypochlorite 2.5% irrigation

root canal instrumentation sodium hypochlorite 2.5% irrigation

Outcomes

Primary Outcome Measures

interleukin 8
Cytokine expression of IL8

Secondary Outcome Measures

Full Information

First Posted
November 27, 2022
Last Updated
January 18, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05653947
Brief Title
Expression of IL-8 Before and After Root Canal Treatment in Patients With Symptomatic Apical Periodontitis
Official Title
Cytokine Expression of IL-8 Before and After Root Canal Treatment in Patients With Symptomatic Apical Periodontitis: Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
November 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This clinical study aimed to Compare the levels of Interleukin 8 before and after root canal treatment in patients with apical periodontitis Diagnosis Local anesthesia Isolation and disinfection of the tooth Two-staged access cavity preparation Patency of the root canals First sample collection using paper points Working length determination Chemico-mechanical preparation After 1 week, isolation, Second sample collection then obturation of the root canals and restoration of the tooth. Samples will be stored in (-80 C) freezer till collection of all samples then, quantification will be done using ELISA.
Detailed Description
Diagnosis: Personal data including name, address and phone number in addition to medical history and dental history will be collected from each patient in specific forms, then history of chief complaint will be recorded. The selected patients should show symptoms of symptomatic apical periodontitis (SAP) either associated with vital or necrotic teeth. Extra-oral and intra-oral clinical examination of the suspected tooth will be performed tentatively using a diagnostic mirror and probe. Radiograph will be taken using bisecting angle technique with a periapical digital sensor. The diagnosis of symptomatic apical periodontitis is confirmed through positive percussion test. After completing the diagnosis, the patient will be enrolled in the study. Treatment procedure: Local anesthesia: Anesthetizing the tooth using infiltration technique by local anesthesia (4% Articiane). Isolation and disinfection: Operative field, including the tooth, the clamp, and rubber dam sheet will be disinfected using 30% hydrogen peroxide followed by 5% sodium hypochlorite solution. Subsequently, 5% sodium thiosulfate will be used to inactivate the disinfecting agents. Access cavity preparation: a 2-stage access cavity preparation will be performed. The first stage involves the removal of caries and/or coronal restorations using sterile diamond bur. In the second stage, before entering the pulp chamber, the cavity will be disinfected according to the previous decontamination protocol. Then, a new round bur and tapered stone with round end will be used for access cavity preparation. 5. Patency of the root canal will be confirmed using stainless steel hand K-files size #10 and #15. First sample collection: (PS-1) The pre-instrumentation periapical sample will be collected before cleaning and shaping by introducing a fine sterile size 15 paper point 2 mm beyond the canal terminus for 1 minute. This procedure will be performed twice. The paper points will be placed in a sterile micro-centrifugation tube, and immediately transferred to a -80 °C freezer until further testing. 6. Working length will be determined using an electronic apex locator then confirmed radiographically to be 1 mm shorter than radiographic apex. Then the canal will be enlarged to size #20. 7. Mechanical preparation will be performed using ProTaper Next rotary files in X-smart endodontic motor with adjusted speed (200rpm) and torque (2Ncm) according to the manufacturer's instructions. The rotary files were introduced inside the canal using ethylenediaminetetraacetic acid (EDTA) gel with the following sequence: Orifice opener (size 40, taper 0.08) will be used to negotiate the coronal one-third of the canal is a slow downward movement without application of pressure. X1 (size 17, taper 0.04), will be used to negotiate the canal till the full working length is reached X2 (size 25, taper 0.06), will be used to full working length is reached X3 (size 30, taper 0.07), will be used to full working length is reached 8. The canal will be thoroughly irrigated with 2.5% sodium hypochlorite (NaOCl) root canal irrigant (5ml for 1 min) using disposable plastic syringe with side vented needle gauge 30 reaching 1 mm short of the working length. All teeth will receive the same volume of irrigant (5 ml prior to instrumentation, 5 ml between each file and 5 ml as final flush after root canal instrumentation to reach a total volume of 25 ml in total). 9. The canal will then be dried by using sterile paper points and then flushed with 5 ml of saline to inactivate the NaOCl. 10. The access cavity will be closed using sterile cotton pellet and temporary filling and patients will be recalled after 1 week. 11. After 1 week, rubber dam will be applied Second sample collection: (PS-2) The post-instrumentation periapical sample will be collected following the same protocol mentioned. Then, master cone verification radiograph will be taken to ensure proper length and fit. Obturation will be done by modified single cone technique using epoxy resin sealer (Adseal) and 4% taper gutta percha cones together with auxillary cones. 12. The access cavity will be restored with composite resin and occlusal contact will be checked. 13. After collection of all the samples, quantification of IL-8 will be determined using ELISA kit before and after root canal instrumentation and irrigation. The kit is used according to the manufacturer's recommendations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis
Keywords
interleukin 8, apical periodontitis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vital teeth
Arm Type
Experimental
Arm Description
root canal instrumentation sodium hypochlorite 2.5% irrigation
Arm Title
Non-vital teeth
Arm Type
Other
Arm Description
root canal instrumentation sodium hypochlorite 2.5% irrigation
Intervention Type
Procedure
Intervention Name(s)
Root canal instrumentation, 2.5% NaOCl irrigation
Intervention Description
Root canal instrumentation, 2.5% NaOCl irrigation
Primary Outcome Measure Information:
Title
interleukin 8
Description
Cytokine expression of IL8
Time Frame
immediately after access cavity preparation and immediately after root canal instrumentation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Medically free patients Single canaled teeth diagnosed clinically with symptomatic apical periodontitis. Radiographic widening in the periodontal membrane space. Presence of pain on percussion. Patients' acceptance to participate in the trial. Exclusion Criteria: Medically compromised patients. Pregnant women: Avoid radiation exposure, anesthesia, and medication. If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively. Teeth that shows association with acute periapical abscess or swelling: Need special treatment steps which could involve additional visits with incision and drainage. Presence of periodontal disease Non restorability Immature teeth Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Giza
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Expression of IL-8 Before and After Root Canal Treatment in Patients With Symptomatic Apical Periodontitis

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