The Effects of EndoActivator on Postoperative Pain and Root Canal Treatment Success

Root Canal Infection Clinical Trial

Official title:

Evaluation of the Effects of EndoActivator Use on Postoperative Pain and Root Canal Treatment Success

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06339905
• Other study ID #: 10840098-772.02-5564
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: May 2024
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Periapical Periodontitis
• Periodontitis
• Root Canal Infection

Intervention

Procedure:
• Sonic Activation with EndoActivator
sonic activation
• Control Needle Irrigation
control group

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University, Faculty of Dentistry	Istanbul	Esenler

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Brito PR, Souza LC, Machado de Oliveira JC, Alves FR, De-Deus G, Lopes HP, Siqueira JF Jr. Comparison of the effectiveness of three irrigation techniques in reducing intracanal Enterococcus faecalis populations: an in vitro study. J Endod. 2009 Oct;35(10):1422-7. doi: 10.1016/j.joen.2009.07.001. — View Citation

Orstavik D. Time-course and risk analyses of the development and healing of chronic apical periodontitis in man. Int Endod J. 1996 May;29(3):150-5. doi: 10.1111/j.1365-2591.1996.tb01361.x. — View Citation

Ramamoorthi S, Nivedhitha MS, Divyanand MJ. Comparative evaluation of postoperative pain after using endodontic needle and EndoActivator during root canal irrigation: A randomised controlled trial. Aust Endod J. 2015 Aug;41(2):78-87. doi: 10.1111/aej.12076. Epub 2014 Sep 4. — View Citation

Swimberghe RCD, Buyse R, Meire MA, De Moor RJG. Efficacy of different irrigation technique in simulated curved root canals. Lasers Med Sci. 2021 Aug;36(6):1317-1322. doi: 10.1007/s10103-021-03263-8. Epub 2021 Feb 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline postoperative pain at 1 week	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.	1,2,3 and 7 days
Primary	change from baseline periapical index at 1 year	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 .	Clinical and radiographic examinations were performed on the 1 day of treatment, and 1 year after treatment.]