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NCT Number: NCT06625853

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

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

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Key information

Conditions

Dental Pain Dental Pulp Diseases Endodontically Treated Teeth Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases Tooth, Nonvital Toothache

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mtwo R files with Xp-Endo finisher file

Other

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.

Mtwo R files

Other

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.

Primary outcomes

  1. Change in pain

    Time frame: 24-hours,48-hours,72hours and 7 days

    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

Secondary outcomes

  1. change in analgesics intake according to severity of pain according to WHO Analgesic Ladder

    Time frame: 24-hours,48-hours,72hours and 7 days

    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.

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2024
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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