Clinical Trial: Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial (Part I

Brief Summary:

  • The aim of this study is to assess the postoperative pain and the intake of analgesic medication after using Reciproc single-file reciprocating system or One Shape single-file continuous rotary system in patients with symptomatic irreversible pulpitis.
  • Patients will be diagnosed to determine whether they are eligible for the inclusion criteria of this study or not. Patients who are eligible will then start their root canal treatment on the same visit and to be completed in one visit only. Patients will be phone called in order to record the intensity of pain, amount and frequency of analgesic intake at 6, 12, 24, 48 and 72 hours after treatment.

Detailed Summary:

- Full medical and dental history using a schematic dental chart will be obtained from all eligible participants. Each tooth will be evaluated for vitality (sensitivity) of pulp tissues.

The patients will be randomly divided into 2 groups:

  • Experimental group: Reciproc reciprocating instrumentation system.

  • Control group: One Shape rotary instrumentation system.

    - Sequence of Procedural steps

    1. Preoperative pain will be assessed by Numerical Rating Scale (NRS) before administration of anesthesia.
    2. Local anesthesia will be achieved using 2% lidocaine (1:100,000 adrenaline).
    3. An access cavity will be performed using round bur and Endo-Z bur.
    4. The tooth will be properly isolated with rubber dam.
    5. Working length will be determined using an electronic apex locator, and working length will be confirmed by radiograph using K-file. Then the working length will be established at 0.5 mm up to the radiographic apex.
    6. Canals will be explored with hand K-file ISO sizes 10, 15, 20.
    7. Mechanical preparation for both groups will be as follows:

  • Experimental group:

    • Canals will be instrumented using Reciproc reciprocating system set on an electric motor, with adjusted torque and speed according to the manufacturer's instructions. Sponsor: Cairo University

      Current Primary Outcome: postoperative pain [ Time Frame: Up to 72 hrs after treatment ]

      Intensity of pain after endodontic treatment by Numerical Rating Scale (0-10)


      Original Primary Outcome: Same as current

      Current Secondary Outcome: Number of analgesic tablets taken after endodontic treatment [ Time Frame: up to 72 hours after treatment ]

      One tablet 600 mg Ibuprofen if patient experiences severe pain after treatment


      Original Secondary Outcome: Same as current

      Information By: Cairo University

      Dates:
      Date Received: October 18, 2016
      Date Started: January 2017
      Date Completion: January 2018
      Last Updated: October 19, 2016
      Last Verified: October 2016