XP-Endo Finisher on Postoperative Pain in Retreatment Cases Using Mtwo R Files

Supplementary Use of the XP-Endo Finisher on Postoperative Pain in Retreatment Cases Using Mtwo R Files (Randomized Clinical Trial)

Introduction: Postoperative pain is one of the most critical issues in our daily practice. , postoperative pain control is essential for patient satisfaction and comfort. When primary root canal treatment fails, root canal retreatment aims to heal apical periodontitis.

Aim of study: To compare between postoperative pain (POS) after endodontic retreatment using NI-TI rotary files Mtwo R alone and in conjunction with XP endo finisher .

Materials and Methods: This research is a randomized clinical trial conducted in a parallel design on 50 patients needing retreatment. They will be divided into two groups, group 1 retreatment with Mtwo R, group 2 retreatment with Mtwo R followed by Xp - Endo finisher. Postoperative pain levels will be evaluated at 24 hours, 48 hours, 72 hours, and 7 days following the removal of the obturation mat erial. The assessment of pain will be done through clinical examination, The Defense and veterans pain rating scale (DVPRS) and by the intake of pain killer

Study Overview

• Status: Completed
• Conditions: Endodontically Treated Teeth; Dental Pain
• Intervention / Treatment: Other: Mtwo R files; Other: Mtwo R files with Xp-Endo finisher file

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Teeth with mature apices.
• Patients with no systemic diseases.
• No analgesic, anti-inflammatory, or antibiotic intake during 7 days before treatment.
• Teeth showing failure of initial root canal treatment and radiograph evidence of periapical bone destruction

Exclusion Criteria:

• Multi rooted teeth.
• Teeth with open apices.
• Teeth with cracks, calcification, root caries, fractures, external or internal resorption.
• Allergies to local anesthetic agents.
• Presence of severe pain and/or acute apical abscesses

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mtwo R files without Xp-endo finisher file.	Other: Mtwo R files; obturation material will be removed using Mtwo R (VDW, Munich, Germany)files attached to an endodontic motor (Ecube, seachin, Korea) with a constant speed of 280 rpm, as suggested by the manufacturer. Mtwo R 25/0.05 will be used to empty the coronal and middle thirds of the root. Mtwo R 15/0.05 will be used to reach the working length.
Experimental: Mtwo R files followed by Xp-Endo finisher file	Other: Mtwo R files with Xp-Endo finisher file; XP-endo Finisher file will be inserted without rotation into the root canals filled with 2.5% NaOCl and will be activated (800 rpm; torque of 1 N.cm) for 1 min in each canal using slow and gentle 7-8 mm lengthwise movements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain	Word descriptors are attached to each number on the DVPRS 0 = No pain; = Hardly noticeable pain; = Noticeable pain, but does not interfere with activities; = Somewhat distracting pain; = Distracting pain, but does not affect normal activities; = Pain interrupts some activities; = Hard to ignore pain, avoidance of daily activities; = Pain is the main focus of attention, prevents daily activities; = Awful pain, difficult to do anything; = Unbearable pain, cannot do anything; = As bad as pain can be, nothing else matters	24-hours,48-hours,72hours and 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in analgesics intake according to severity of pain according to WHO Analgesic Ladder	First Step - Mild pain: non-opioid analgesics such as nonsteroidal antiinflammatory drugs (NSAIDs) or acetaminophen with or without adjuvants.; Second Step - Moderate pain: weak opioids (hydrocodone, codeine, tramadol) with or without non-opioid analgesics and with or without adjuvants.; Third Step - Severe and persistent pain: potent opioids (morphine, methadone, fentanyl, oxycodone, buprenorphine, tapentadol, hydromorphone, oxymorphone) with or without non-opioid analgesics, and with or without adjuvants.	24-hours,48-hours,72hours and 7 days

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Actual): April 23, 2024
• Study Completion (Actual): April 23, 2024

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Tooth, Nonvital
• Other Study ID Numbers: 0738-08/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No