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

May 3, 2024 updated by: yeldaerdem, Istanbul Medipol University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Esenler
      • Istanbul, Esenler, Turkey
        • Istanbul Medipol University, Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional needle irrigation (control)
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
control group
Other Names:
  • CNI
Experimental: Sonic Activation with EndoActivator
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
sonic activation
Other Names:
  • EndoActivator (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1,2,3 and 7 days
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 .
Clinical and radiographic examinations were performed on the 1 day of treatment, and 1 year after treatment.]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Principal Investigator: Seyda Ersahan, PhD, Istanbul Medipol University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10840098-772.02-5564

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After its publication in a journal, the investigators want to share their data.

IPD Sharing Time Frame

After its publication in a journal, the investigators want to share their data.

IPD Sharing Access Criteria

Postoperative pain scores, radiographic and clinical findings.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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