The Impact Of Different Final Irrigation Activation Techniques On Postoperative Pain In Single Rooted Mandibular Premolar Teeth: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sinai University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- The Impact Of Different Final Irrigation Activation Techniques On Postoperative Pain
Study Overview
Brief Summary
The trial was conducted to assess the impact of passive ultrasonic irrigation, XP endo finisher, AF max file, and manual dynamic agitation on postoperative pain and analgesic consumption at 6 h., 12 h., 24 h., 48 h., 72 h., and a week later on single-rooted lower premolar teeth with acute irreversible pulpitis and apical periodontitis.
Detailed Description
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. Intraoral clinical examination had revealed either extensive restoration or a history of significant caries. Digital periapical x-rays had been used to assess the following factors: tooth structure, extensive caries, improper fillings, periapical tissue condition, and periodontal support. Whenever the regular x-rays disclosed participants with doubt of more than one canal, cone beam computed tomography (CBCT) was used to exclude. The inclusion guidelines for individuals' restorable teeth with a normal periodontal score index of less than two were as follows: severe preoperative pain (Vas score 3), discomfort response on biting/mastication or percussion but no mobility. Discomfort response on palpation of surrounding tissue but with no intraoral swelling. The inclusion criteria also include patients who stopped medications for the last 12 hours before the procedure. Additionally, the radiograph showed only normal or slight widening in the periodontal ligament space of the affected root. The exclusion criteria included patients with any serious systemic disease, those under the age of eighteen or incapable of giving informed consent, those over forty, those with severe preoperative pain on biting/mastication or percussion, those with a mandibular premolar involving multiple canals or huge periapical pathosis, open apices, periodontal involvement, retreated cases, sinus tract presence, and swelling of surrounding soft tissues; in addition to those, patients who had been pregnant and allergic patients with local anesthetic agents.(15) 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 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
double (participants ,outcome assessors)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •solitary-rooted lower premolar teeth with acute irreversible pulpitis and apical periodontitis who were in the age range between 18 and 40 years old.
- •Each patient received root canal treatment in one session.
- •restorable teeth with a normal periodontal score index of less than two
- •severe preoperative pain (Vas score 3)
- •discomfort response on biting/mastication or percussion but no mobility.
- •Discomfort response on palpation of surrounding tissue but with no intraoral swelling.
- •Patients who stopped medications for the last 12 hours before the procedure
- •The radiograph showed only normal or slight widening in the periodontal ligament space of the affected root.
Exclusion Criteria
- •patients with any serious systemic disease
- •Patients under the age of eighteen or incapable of giving informed consent
- •Patients over forty
- •Patients with a mandibular premolar involving multiple canals or huge periapical pathosis
- •Patients with severe preoperative pain on biting/mastication or percussion
- •Mandibular premolar with open apices
- •Mandibular premolar with periodontal involvement
- •Retreated cases, sinus tract presence, and swelling of surrounding soft tissues
- •patients who had been pregnant and allergic patients with local anesthetic agents
Arms & Interventions
XP Endo finisher
technique used for final irrigation in vertical lengthwise movement to the full working length for 1 minute in each canal.
Intervention: Instruments (Other)
Passive Ultrasonic Irrigation
technique used for final irrigation in vertical strokes reaching 2 mm short from the full working length for 1 minute in each canal.
Intervention: Instruments (Other)
Fanta AF max file
technique used for final irrigation in vertical lengthwise movement to the full working length for 1 minute in each canal.
Intervention: Instruments (Other)
Manual Dynamic agitation
technique used for final irrigation in Intermittent manual activation for 1 min in up-and-down motion using master gutta percha cone was performed.
Intervention: Instruments (Other)
Outcomes
Primary Outcomes
The Impact Of Different Final Irrigation Activation Techniques On Postoperative Pain
Time Frame: 6, 12, 24, 48, 72 hours and I week after completion of root canal treatment.
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; 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Yasmin Tawfik Mohamed Sobh
Endodontic lecturer
Sinai University
