Evaluation of the Effects of EndoActivator Use on Postoperative Pain and Root Canal Treatment Success
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istanbul Medipol University Hospital
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- change from baseline postoperative pain at 1 week
Overview
Brief Summary
This study evaluates postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using EndoActivator for irrigation activation.
Detailed Description
Aim: To evaluate postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using EndoActivator for irrigation activation.
Methodology: In this clinical trial, root-canal treatment was performed on 140 posterior teeth with chronic apical periodontitis. After routine canal preparation, patients were assigned to either a control group treated using conventional needle irrigation (CNI) without activation or to sonic irrigation activation with EndoActivator. All treatment was completed in a single visit. Patients provided self-assessments of the severity of postoperative pain at 1, 2,3 and 7 days using a Verbal Rating Scale (VRS) and Wong Baker Face Scale. Patients were recalled at 12 months for clinical and radiographic examinations. Periapical healing was evaluated using a periapical index (PAI), with scores of 1 or 2 considered to represent treatment success and scores of 3, 4, or 5 to represent treatment failure. Data were analyzed using one-way ANOVA and Kruskal-Wallis tests, with differences of P < 0.05 considered statistically significant.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18-60 patient's age
- •Being systemically healthy
- •Having posterior teeth (molar or premolar) with chronic apical periodontitis lesion (PAI≥3)
Exclusion Criteria
- •Clinically symptomatic teeth
- •Patients with complicated systemic disease (ASA 3 - 6)
- •Teeth with open apex
- •Teeth having curvature more than 20 degree
- •Not having enough tooth structure to be isolated with rubber dam
- •Patients with severe periodontal defects or deep periodontal pockets (probing depth\> 4 mm)
- •A history of taking analgesics 12 hours ago or antibiotics 1 month ago
- •Patients who cannot come to control sessions
Outcomes
Primary Outcomes
change from baseline postoperative pain at 1 week
Time Frame: 1,2,3 and 7 days
Pain was measured using a Verbal Rating Scale with 4 levels, as follows: 0, no pain; 1, slight pain (mild discomfort, no treatment needed); 2, moderate pain (pain required analgesics for relief); 3, severe pain (pain and/or swelling not relieved by simple analgesics and required unscheduled visit) and Wong Baker Face Scale with six different facial expression. Patients were provided forms and asked to record preoperative pain as well as pain at 1,2,3 and 7 days postoperatively, and to note down the number of analgesics taken. Patients returned their completed forms at their 1-week follow-up visits.
change from baseline periapical index at 1 year
Time Frame: Clinical and radiographic examinations were performed on the 1 day of treatment, and 1 year after treatment.]
Periapical tissue was evaluated using a 5-point periapical index (PAI) (Ørstavik et al. 1986) and scored as follows: 1: Normal periapical structures; 2: Small changes in bone structures; 3: Changes in bone structure with some mineral loss; 4: Periodontitis with well-defined radiolucent area; 5: Severe periodontitis with exacerbating features. Treatment was considered successful if the patient had no discomfort, no percussion/palpation pain, no sinus tract, no mobility or associated soft-tissue swelling, and a PAI score of ≤ 2. Treatment was considered a failure if the patient could not perform normal masticatory functions, experienced discomfort and percussive pain upon examination, and/or had a PAI score of ≥ 3 .
Secondary Outcomes
No secondary outcomes reported
Investigators
yeldaerdem
Director, Clinical Research
Istanbul Medipol University Hospital