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

NCT06625853 | Completed

• 1 other identifier: 0738-08/2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Pain; Endodontically Treated Teeth

Outcome Measures

Primary Outcomes (1)

• Change in pain

  Word descriptors are attached to each number on the DVPRS 0 = No pain 1. = Hardly noticeable pain 2. = Noticeable pain, but does not interfere with activities 3. = Somewhat distracting pain 4. = Distracting pain, but does not affect normal activities 5. = Pain interrupts some activities 6. = Hard to ignore pain, avoidance of daily activities 7. = Pain is the main focus of attention, prevents daily activities 8. = Awful pain, difficult to do anything 9. = Unbearable pain, cannot do anything 10. = As bad as pain can be, nothing else matters

  24-hours,48-hours,72hours and 7 days

Secondary Outcomes (1)

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

  24-hours,48-hours,72hours and 7 days

Study Arms (2)

Mtwo R files without Xp-endo finisher file.

EXPERIMENTAL

Other: Mtwo R files

Mtwo R files followed by Xp-Endo finisher file

EXPERIMENTAL

Other: Mtwo R files with Xp-Endo finisher file

Interventions

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 followed by Xp-Endo finisher file

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.

Mtwo R files without Xp-endo finisher file.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

MeSH Terms

Conditions

Toothache; Tooth, Nonvital

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dental Pulp Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: September 12, 2023
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Locations

EG (1)