Expression of IL-8 Before and After Root Canal Treatment in Patients With Symptomatic Apical Periodontitis
Condition: Apical Periodontitis
MeSH terms: Periodontitis; Periapical Periodontitis
Study type: Interventional

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:

        1. Local anesthesia: Anesthetizing the tooth using infiltration technique by local
           anesthesia (4% Articiane).

        2. 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.

        3. 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.
    

Intervention name(s): Root canal instrumentation, 2.5% NaOCl irrigation
Intervention type(s): Procedure
Intervention description(s): Root canal instrumentation, 2.5% NaOCl irrigation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: interleukin 8; apical periodontitis