Clinical trial NCT06339905: The Effects of EndoActivator on Postoperative Pain and Root Canal Treatment Success
Official title: Evaluation of the Effects of EndoActivator Use on Postoperative Pain and Root Canal Treatment Success
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periapical Periodontitis
Root Canal Infection
Keywords: Chronic apical periodontitis
irrigation activation
periapical index
postoperative pain
treatment outcome
periapical health
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: change from baseline postoperative pain at 1 week
timeFrame: 1,2,3 and 7 days
measure: change from baseline periapical index at 1 year
timeFrame: Clinical and radiographic examinations were performed on the 1 day of treatment, and 1 year after treatment.]
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University, Faculty of Dentistry
state: Esenler
Study officials:
affiliation: Istanbul Medipol University Hospital
name: Seyda Ersahan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.