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

NCT06339905 | Completed DMC

• 1 other identifier: 10840098-772.02-5564
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Periapical Periodontitis; Root Canal Infection

Keywords

Chronic apical periodontitis; irrigation activation; periapical index; postoperative pain; treatment outcome; periapical health

Outcome Measures

Primary Outcomes (2)

• 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

• 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.]

Study Arms (2)

Sonic Activation with EndoActivator

EXPERIMENTAL

Sonic irrigation was performed using an EndoActivator sonic handpiece (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA). A suitable-size activator tip was selected and loosely placed at 2 mm from working length, and the device was operated at 10,000 cycles/min using a pumping action to move the tip to produce vertical strokes of 2-3 mm.

Procedure: Sonic Activation with EndoActivator

Conventional needle irrigation (control)

ACTIVE COMPARATOR

Conventional needle irrigation was performed with short, in-and-out vertical strokes of 2-3 mm at a rate of approximately 100 strokes per minute.

Procedure: Control Needle Irrigation

Interventions

Sonic Activation with EndoActivator PROCEDURE

sonic activation

Also known as: EndoActivator (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA)

Sonic Activation with EndoActivator

Control Needle Irrigation PROCEDURE

control group

Also known as: CNI

Conventional needle irrigation (control)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patient's age
• Being systemically healthy
• Having posterior teeth (molar or premolar) with chronic apical periodontitis lesion (PAI≥3)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University, Faculty of Dentistry

Istanbul, Esenler, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 9206419 BACKGROUND

• 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.

  PMID: 25195661 BACKGROUND

• 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.

  PMID: 33624186 BACKGROUND

• 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.

  PMID: 19801244 BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Seyda Ersahan, PhD

  Istanbul Medipol University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: January 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2023
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After its publication in a journal, the investigators want to share their data.
• Access Criteria: Postoperative pain scores, radiographic and clinical findings.

Locations

TU (1)