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Comparison Between Reciproc and Oneshape Systems

Primary Purpose

Pulpitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reciproc single file system
One Shape single file system
X-smart Plus, Dentsply Maillefer, Ballaigues, Switzerland
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mandibular premolar teeth with:

    • Single canal
    • Preoperative sharp pain.
    • Vital response of pulp tissue.
    • Normal periapical radiographic appearance or slight widening in lamina dura.
  • Final diagnosis for an eligible patient will take place by radiograph and pulp testing.

Exclusion Criteria:

  • Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment.
  • Patients who have more than one tooth in the same quadrant and/or opposite quadrant that require an endodontic treatment.
  • Pregnant females.
  • Patients having significant systemic disorder.
  • If antibiotics have been administrated during the past two weeks preoperatively.
  • Patients having bruxism or clenching.
  • Teeth that have:

    • Non-vital pulp tissues.
    • Association with swelling or fistulous tract.
    • A pocket depth greater than 5 mm.
    • Previous endodontic treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Reciproc single file system

    One Shape single file system

    Arm Description

    It is a reciprocating NiTi file used for instrumentation of root canals in endodontic treatment

    It is a rotary NiTi file used for instrumentation of root canals in endodontic treatment

    Outcomes

    Primary Outcome Measures

    Assessment of the change in postoperative pain measured by the Numerical Rating Scale (0-10)
    Pain intensity after root canal treatment will be measured using Numerical Rating Scale (0-10)

    Secondary Outcome Measures

    Number of analgesics taken by the patient
    It will be recorded by the patient with time intervals

    Full Information

    First Posted
    October 19, 2016
    Last Updated
    October 19, 2016
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02940782
    Brief Title
    Comparison Between Reciproc and Oneshape Systems
    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 Two
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    October 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 Description
    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: Assessment of preoperative pain by NRS before administration of anesthesia. Administration of local anesthesia using 2% lidocaine (1:100,000 adrenaline). An access cavity will be done using a round bur and Endo-Z bur. Isolation of the affected tooth with rubber dam. 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. Canals will be explored with hand K-file ISO sizes 10, 15, 20. 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 Glidden drill or an orifice opener since the design of the Reciproc instrument allows any obstructions in the coronal third to be removed, as claimed by the manufacturer. Reciproc file selection: R40 (40/0.06) Control group: Coronal preflaring will be performed using Gates Glidden drill. Canals will be instrumented using One Shape single-file (25/0.06) set on an electric motor with adjusted torque and speed according to the manufacturer's instructions. For wide canals, One Shape Apical (30/0.06, 37/0.06) will be used. The rotary files will be introduced inside the canal using EDTA gel. Canals will be irrigated with 2.6% sodium hypochlorite solution between every subsequent instrument. It is prepared by adding 10 ml of sterile distilled water to 10 ml of 5.25% sodium hypochlorite solution using a 27 gauge needle fit to 5ml disposable plastic syringe placed in the canal space without binding. Canals will be dried with sterile paper points and obturated using lateral condensation technique. A spreader will be used to allow space for auxiliary cones, with resin-based root canal sealer. The tooth will be sealed by temporary restoration, and postoperative pain will be assessed immediately after the end of treatment. The patient will be phone called for follow up after 6, 12, 24, 48 and 72 hours. The patient will be instructed to return to complete the treatment procedures until placing a full-coverage restoration. The patient will be instructed to take one tablet 600 mg Ibuprofen if he/she experiences severe pain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulpitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    54 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Reciproc single file system
    Arm Type
    Experimental
    Arm Description
    It is a reciprocating NiTi file used for instrumentation of root canals in endodontic treatment
    Arm Title
    One Shape single file system
    Arm Type
    Active Comparator
    Arm Description
    It is a rotary NiTi file used for instrumentation of root canals in endodontic treatment
    Intervention Type
    Procedure
    Intervention Name(s)
    Reciproc single file system
    Intervention Description
    A reciprocating Nickel Titanium single file system used for instrumentation of root canals in endodontic treatment.
    Intervention Type
    Procedure
    Intervention Name(s)
    One Shape single file system
    Intervention Description
    A rotary Nickel Titanium single file system used for instrumentation of root canals in endodontic treatment.
    Intervention Type
    Device
    Intervention Name(s)
    X-smart Plus, Dentsply Maillefer, Ballaigues, Switzerland
    Intervention Description
    It is a micro-motor designed for performing root canal treatments with the reciprocating, single file technique or traditional continuous rotation file system.
    Primary Outcome Measure Information:
    Title
    Assessment of the change in postoperative pain measured by the Numerical Rating Scale (0-10)
    Description
    Pain intensity after root canal treatment will be measured using Numerical Rating Scale (0-10)
    Time Frame
    Immediately after treatment, then 6 hours, 12 hours, 24 hours and 72 hours after treatment.
    Secondary Outcome Measure Information:
    Title
    Number of analgesics taken by the patient
    Description
    It will be recorded by the patient with time intervals
    Time Frame
    72 hours from the end of the endodontic treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Mandibular premolar teeth with: Single canal Preoperative sharp pain. Vital response of pulp tissue. Normal periapical radiographic appearance or slight widening in lamina dura. Final diagnosis for an eligible patient will take place by radiograph and pulp testing. Exclusion Criteria: Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment. Patients who have more than one tooth in the same quadrant and/or opposite quadrant that require an endodontic treatment. Pregnant females. Patients having significant systemic disorder. If antibiotics have been administrated during the past two weeks preoperatively. Patients having bruxism or clenching. Teeth that have: Non-vital pulp tissues. Association with swelling or fistulous tract. A pocket depth greater than 5 mm. Previous endodontic treatment.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed A Soliman, B.D.S
    Phone
    +20-01003564036
    Email
    aasoliman89@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed A Soliman, B.D.S
    Organizational Affiliation
    Faculty of Oral and Dental Medicine, Cairo University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Angie G Ghoneim
    Organizational Affiliation
    Faculty of Oral and Dental Medicine, Cairo University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Shaimaa I Gawdat
    Organizational Affiliation
    Faculty of Oral and Dental Medicine, Cairo University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25773449
    Citation
    Neelakantan P, Sharma S. Pain after single-visit root canal treatment with two single-file systems based on different kinematics--a prospective randomized multicenter clinical study. Clin Oral Investig. 2015 Dec;19(9):2211-7. doi: 10.1007/s00784-015-1448-x. Epub 2015 Mar 15.
    Results Reference
    background
    PubMed Identifier
    26614017
    Citation
    Kherlakian D, Cunha RS, Ehrhardt IC, Zuolo ML, Kishen A, da Silveira Bueno CE. Comparison of the Incidence of Postoperative Pain after Using 2 Reciprocating Systems and a Continuous Rotary System: A Prospective Randomized Clinical Trial. J Endod. 2016 Feb;42(2):171-6. doi: 10.1016/j.joen.2015.10.011. Epub 2015 Nov 29.
    Results Reference
    background

    Learn more about this trial

    Comparison Between Reciproc and Oneshape Systems

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