Clinical Trial: Comparison Between Reciproc and Oneshape Systems

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

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

Brief Summary: A randomized clinical trial to assess postoperative pain in patients with symptomatic irreversible pulpitis after using Reciproc versus One Shape rotary NiTi Systems.

Detailed Summary:

The study aims at comparing postoperative pain after using two single-file NiTi systems, Reciproc reciprocating system and One Shape rotary system, for root canal instrumentation in patients with symptomatic irreversible pulpitis.

After the patient is found eligible, he/she will be randomly assigned to either the control (One Shape) or experimental group (Reciproc) and will be treated in a single visit.

Sequence of Procedural Steps:

  1. Assessment of preoperative pain by NRS before administration of anesthesia.
  2. Administration of local anesthesia using 2% lidocaine (1:100,000 adrenaline).
  3. An access cavity will be done using a round bur and Endo-Z bur.
  4. Isolation of the affected tooth with rubber dam.
  5. Determination of the working length using an electronic apex locator, and confirmed by a 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.
      • There is no need for coronal preflaring with a Gates Glidd
        Sponsor: Cairo University

        Current Primary Outcome: Assessment of the change in postoperative pain measured by the Numerical Rating Scale (0-10) [ Time Frame: Immediately after treatment, then 6 hours, 12 hours, 24 hours and 72 hours after treatment. ]

        Pain intensity after root canal treatment will be measured using Numerical Rating Scale (0-10)


        Original Primary Outcome: Same as current

        Current Secondary Outcome: Number of analgesics taken by the patient [ Time Frame: 72 hours from the end of the endodontic treatment ]

        It will be recorded by the patient with time intervals


        Original Secondary Outcome: Same as current

        Information By: Cairo University

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