The Impact Of Different Final Irrigation Activation Techniques On Postoperative Pain

this trial will aim to evaluate postoperative pain in terms of incidence and intensity and the frequency rate of analgesic intake in patients with carious pulp exposure and symptomatic irreversible pulpitis with apical periodontitis after single-visit endodontic treatment of single rooted mandibular premolars using PUI or XPF, Fanta AF max file and dynamic manual agitation in the final irrigation protocol in a randomized clinical trial Postoperative pain will be assessed using a VRS 6, 12, 24, 48, 72 hours and I week after completion of root canal treatment.

Selection of cases:

A total number of sixty-four patients in the 18-40 age range will be enrolled for the study from the outpatient clinic of restorative department of Sinai university (Kantara branch). The selected patients will have a carious pulp exposure that will be selected according to the inclusion and exclusion criteria to participate in this study. the procedure, possible discomfort and benefits will be explained to the patients. Informed consent will be obtained from the patients prior to study which includes root canal treatment in a single visit of single rooted mandibular premolar teeth with carious pulp exposure and symptomatic irreversible pulpitis with apical periodontitis, and both verbal and written consent is advisable. Before initiation of treatment, the whole procedural steps will be explained to the patients. Then the patients will sign an informed consent form.

Sample size:

Sample size calculation was performed using G\*Power version 3.1.9.7 based on the results of a previous study) (13). A power analysis was designed to have adequate power to apply a two-sided statistical test to reject the null hypothesis that there is no difference between groups. By adopting an alpha level of (0.05) and a beta of (0.2), i.e. power = 80% and an effect size (d) of (0.55) calculated based on the results of a previous study. The predicted sample size (n) will be (64), i.e., 16 samples per group. To detect for different postoperative pain between groups Patient Selection Criteria Systemically healthy patients with single rooted mandibular premolar teeth with oval canals diagnosed with carious pulp exposure and symptomatic irreversible pulpitis with apical periodontitis will be included in the study. The diagnosis will be based on clinical findings, including pain level and its characteristics, intensity, duration, frequency, and provoking and relieving factors. An intraoral clinical examination will be carried out using a diagnostic mirror and probe. The presence of extensive caries or recurrent caries with large restoration will be identified. Radiographic examination will be performed with a periapical film (Dental film, speed D, size 2, Kodak Co., NY, USA) using the parallel technique to evaluate tooth structure, deep caries proximity, number of canals, previous defective restorations, periapical status, and periodontal support. Restorable teeth with normal periodontal scoring index \<2, Absence of mobility tenderness on percussion associated with normal periapical radiograph or slight widening of periodontal membrane space will be considered as inclusion criteria(14) .The exclusion criteria will be included patients suffering from any significant systemic disorder; patients incapable of providing informed self-consent or below the age of 18; patients over the age of 45, patients having a mandibular premolar with periapical involvement or more than one canal , Teeth with pulp necrosis, open apices ,no tenderness to percussion ,periodontal involvement, palpation of adjacent soft tissues, Presence of sinus tract, Retreated cases .Pregnant women, patients who will be allergic to local anesthetic agents; and patients who will take medications (antibiotics, analgesics, or anti-inflammatory drugs) seven days before the procedure(13).

All participants will be informed about the study, and their consent will be obtained before treatment. A list for random participant assignment will be generated by a randomization software. This randomization will be performed by an operator not involved in the study. An ethyl chloride cold pulp tester will be used to detect the affected tooth's response and the adjacent and contralateral teeth (used as control) to ensure that the tester will work properly and that the participants responds adequately. The preoperative pain level will be assessed by giving each participant a pain scale chart (VRS) to record the pain level before any intervention. Clinical and radiographic data of each patient will be attached to their clinical notes and analyzed by 2 experienced endodontists.

Preparation of the patient: - Before the preparation and restoration visit, all patients will be subjected to full mouth scaling and will be given proper oral hygiene instruction.

Clinical Steps

All root canal procedures will be performed in a single visit by an experienced clinician. An inferior alveolar nerve block (4% Mepivicaine HCl \& 1:100,000 Adrenaline) will be used to anaesthetize the tooth. After the removal of decay and restoration buildup, a rubber dam (Sanctuary Dental Dam Systems, Ipoh, Malaysia) will be applied, and an access cavity will be performed using a size 2 round bur (Dentsply Maillefer, Ballaigues, Switzerland) and an Endo-Z bur (Dentsply Maillefer). Canal patency will be confirmed with a 15 K file (Dentsply Maillefer). The working length, set at 1 mm short of the radiographic apex, will be determined using an electronic apex locator (Root ZX, J. Morita, Tokyo, Japan), and then will be confirmed radiographically. The Protaper Next (PTN) rotary system (Dentsply Maillefer) will be used to mechanically prepare the root canals in a crown-down technique using an endodontic motor (XSmart, Dentsply Maillefer, Ballaigues, Switzerland) with an adjusted torque of 2 Ncm and speed of 300 rpm according to the manufacturer's instructions. PTN rotary system (Dentsply Maillefer) will be used as follows: X1, X2, X3 followed by X4 as the master apical file. All files will be used in a pecking motion to the full working length. Irrigation of the root canals will be performed using 3 ml of 2.5% NaOCl solution delivered by a plastic disposable syringe (S-S disposable syringe, Sung Shim Medical, Bucheon, Korea) with a 30-gauge needle (NaviTip, Ultradent, UT, USA) after each file for 1 minute. Then, it will be introduced passively without forcefully dispensing the irrigant and placed 2 mm from the working length. Participants will be divided into four groups (16 participants for each group) according to the final irrigation protocol as follow:

Group 1: XP-endo Finisher Group 2: Passive Ultrasonic Irrigation Group 3: Fanta AF max file Group 4: Manual dynamic agitation Irrigant replenishment will be performed in all groups to remove loose debris. Afterwards, agitation and replenishment cycles will be repeated twice. The canals will be finally flushed with 3 ml of saline for 1 minute. Sterile paper points (Meta Biomed, Cheongju City, Korea) that correspond to the master cone size will be used to dry the canals. The canals will be obturated using lateral compaction technique. Then, the access cavity will be sealed with temporary filling material of sufficient thickness. A postoperative radiograph will be taken, and each patient will be instructed to take 400 mg of ibuprofen every 6 hours in case of severe pain (14-15) post operative evaluation

Patients will be informed about the possible development of pain. Postoperative pain will be assessed using a VRS 6, 12, 24, 48, 72 hours and I week after completion of root canal treatment. The VRS consisted of a four-step pain scale using a continuous 0-3 point scale (16-17); No pain (0): the treated tooth felt normal. Patients did not have any pain or discomfort, mild (1): recognizable, not discomforting), moderate (2): discomforting, but bearable, and severe (3): considerable discomfort, difficult to bear. Each participant will be given a chart to record the level of postoperative pain and the frequency rate of the analgesic intake.

Statistical analysis: - The collected data will be, tabulated, and statistically analyzed using SPSS program (Statistical Package for Social Sciences) software version 23.0. Descriptive statistics will be done for numerical parametric data as mean±SD (standard deviation) and minimum \& maximum of the range and for numerical non parametric data as median and 1st\& 3rd inter-quartile range, while they will be done for categorical data as number and percentage. Inferential analyses will be done for quantitative variables using independent t-test in cases of two independent groups with parametric data and Mann Whitney U in cases of two independent groups with non-parametric data.

Inferential analyses will be done for qualitative data using Chi square test for independent groups. The level of significance will be taken at P value \<0.050 is significant, otherwise is non-significant. The p-value is a statistical measure for the probability that the results observed in a study could have occurred by chance.

Eligibility Criteria:
Inclusion Criteria:

* single rooted mandibular premolar teeth with oval canals diagnosed with carious pulp exposure and symptomatic irreversible pulpitis with apical periodontitis .
* presence of extensive caries or recurrent caries with large restoration .
* Restorable teeth with normal periodontal scoring index \<2.
* Absence of mobility .
* presence of tenderness on percussion
* normal periapical radiograph or slight widening of periodontal membrane space

Exclusion Criteria:

* absence of patients with systemic disorder
* Teeth with periapical involvement or more than one canal
* Teeth with pulp necrosis or open apices
* teeth with no tenderness to percussion
* Presence of sinus tract
* Retreated cases .
* Pregnant women.
* Patients who will be allergic to local anesthetic agents.
* patients who will take medications (antibiotics, analgesics, or anti-inflammatory drugs) seven days before the procedure