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Assessment of Postoperative Pain Using Reciproc Versus One Shape Files in Patients With Irreversible Pulpitis

Primary Purpose

Pulpitis - Irreversible

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reciproc single-file
One Shape single-file
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible focused on measuring Rotation, Reciprocation, single file, postoperative pain, Reciproc, One Shape, Symptomatic irreversible pulpitis

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • i. Age 25-45years old. ii. Males or Females. iii. Mandibular premolar teeth with:

    • Single canal
    • Preoperative sharp pain.
    • Vital response of pulp tissue.
    • Normal periapical radiographic appearance or slight widening in lamina dura.

Exclusion Criteria:i. Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment.

ii. Patients who have more than one tooth in the same quadrant and/or opposite quadrant that require an endodontic treatment.

iii. Pregnant females. iv. Patients having significant systemic disorder. v. If antibiotics have been administrated during the past two weeks preoperatively.

vi. Patients having bruxism or clenching. vii. 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.

    One Shape single-file .

    Arm Description

    The Reciproc is a single-file nickel-titanium systems used in reciprocating motion, made of a special nickel-titanium (NiTi) alloy called M-Wire created by innovated thermal treatment process which increases flexibility and improved resistance to cyclic fatigue .

    One Shape is single file made of austenite 55- NiTi alloy characterized by different cross sectional designs ,it is used in continuous clockwise rotation for a quick and safe root canal preparation due to its flexibility and minimal fatigue. with electropolished safety tip instrument for enhanced cutting efficiency and it is delivered in a sterile blister for single use.

    Outcomes

    Primary Outcome Measures

    Intensity of pain after endodontic treatment
    Intensity of postoperative pain will be measured using a numerical rating scale (NRS)

    Secondary Outcome Measures

    Number of analgesic tablets taken by the patient after endodontic treatment

    Full Information

    First Posted
    October 31, 2016
    Last Updated
    November 2, 2016
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02953912
    Brief Title
    Assessment of Postoperative Pain Using Reciproc Versus One Shape Files in Patients With Irreversible Pulpitis
    Official Title
    Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems in Patients With Symptomatic Irreversible Pulpitis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    October 2017 (Anticipated)
    Study Completion Date
    January 2018 (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
    To show whether One Shape rotary system differs from Reciproc reciprocating system in postoperative pain in patients with symptomatic irreversible pulpitis.
    Detailed Description
    Patients in the clinic of endodontics at the faculty of oral and dental medicine, Cairo University, Urban area, Cairo governorate, Egypt. The dental Unit is Adec 200 U.S.A. The x-ray Machine is ViVi, S.r.I, Italy The x-ray films are Kodac, speed D, size 2. The operator is master degree student in the department of Endodontics. No dental assistant Time: 2016-2017 Diagnosis The diagnostic data will be collected in a case report form by the investigator and confirmed for eligibility with the assistant supervisor and will be enrolled in the study in the same day. Diagnosis is done by the following: Recording the chief complaint and history of pain Clinical examination will be evaluated for (sensitivity) of pulp tissues using cold testing (by using Green Endo ice), electric tester. The patient should experience prolonged response to cold testing and positive response to electric pulp testing Radiographic examination: There should be no periapical radiolucency except for widening periodontal ligaments. Intervention Full medical and dental history using a schematic dental chart will be obtained from all patients treated during this study. Each tooth will be evaluated for vitality (sensitivity) of pulp tissues using electric pulp tester. The patients will be randomly divided into 2 group: Experimental group Reciproc single-file reciprocating instrumentation system. Control group One Shape single-file rotary instrumentation system. Sequence of Procedural steps Preoperative pain will be assessed by NRS before administration of anesthesia. Local anesthesia will be achieved using 2% lidocaine (1:100,000 adrenaline). An access cavity will be performed using round bur and Endo-Z bur1. . The tooth will be properly isolated with rubber dam. Working length will be determined using an electronic apex locator2, and working length will be confirmed by radiograph using K-file3. 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 Reciproc4 reciprocating system set on an electric motor5, with adjusted torque and speed according to the manufacturer's instruction. 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 - Reciproc file selection: R40 (40/0.06) manufacturer. Control group Coronal preflaring will be performed using Gates Glidden drill. Canals will be instrumented using One Shape1 single-file (25/0.06) set on an electric motor2 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 gel3.. Canals will be irrigated with 2.5% sodium hypochlorite solution between every subsequent instrument. It is prepared by adding 11 ml of sterile distilled water 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. Outcomes Primary Outcome :Intensity of postoperative pain will be measured using a numerical rating scale (NRS) immediately after the end of treatment, 6, 12, 24, 48, and 72 hours after the end of endodontic treatment. The numerical rating scale (0-10 scale) consists of a line anchored by two extremes "0: no pain" and "10: severe pain"; patients will be asked to choose the mark that represents their level of pain from 0 to 10. Pain level will be assigned to one of 4 categorical scores: 0, None; 1, Mild (1-3); 2, Moderate (4-6); 3, Severe (7-10) 0: None Mild (1-3) Moderate (4-6) Severe (7-10) Secondary outcome Number of analgesic taken by the patient to decrease postoperative pain up to 3 days after the end of endodontic treatment will be recorded by the patient with time intervals. Participant Timeline: 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. At the end of treatment, patients will be asked to record postoperative pain by NRS immediately, then after 6,12,24,48 and 72 hours.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulpitis - Irreversible
    Keywords
    Rotation, Reciprocation, single file, postoperative pain, Reciproc, One Shape, Symptomatic irreversible 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.
    Arm Type
    Experimental
    Arm Description
    The Reciproc is a single-file nickel-titanium systems used in reciprocating motion, made of a special nickel-titanium (NiTi) alloy called M-Wire created by innovated thermal treatment process which increases flexibility and improved resistance to cyclic fatigue .
    Arm Title
    One Shape single-file .
    Arm Type
    Active Comparator
    Arm Description
    One Shape is single file made of austenite 55- NiTi alloy characterized by different cross sectional designs ,it is used in continuous clockwise rotation for a quick and safe root canal preparation due to its flexibility and minimal fatigue. with electropolished safety tip instrument for enhanced cutting efficiency and it is delivered in a sterile blister for single use.
    Intervention Type
    Procedure
    Intervention Name(s)
    Reciproc single-file
    Intervention Description
    The Reciproc is a single-file nickel-titanium systems , made of a special nickel-titanium (NiTi) alloy called M-Wire created by innovated thermal treatment process which increases flexibility and improved resistance to cyclic fatigue
    Intervention Type
    Procedure
    Intervention Name(s)
    One Shape single-file
    Intervention Description
    One Shape is one of the few single file made of austenite 55- NiTi alloy characterized by different cross sectional designs ,it is used in continuous clockwise rotation for a quick and safe root canal preparation due to its flexibility and minimal fatigue.In addition to , the electropolished safety tip instrument for enhanced cutting efficiency and it is delivered in a sterile blister for single use.
    Primary Outcome Measure Information:
    Title
    Intensity of pain after endodontic treatment
    Description
    Intensity of postoperative pain will be measured using a numerical rating scale (NRS)
    Time Frame
    immediately after the end of treatment up to 72 hours
    Secondary Outcome Measure Information:
    Title
    Number of analgesic tablets taken by the patient after endodontic treatment
    Time Frame
    Within 3 days after endodontic treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: i. Age 25-45years old. ii. Males or Females. iii. Mandibular premolar teeth with: Single canal Preoperative sharp pain. Vital response of pulp tissue. Normal periapical radiographic appearance or slight widening in lamina dura. Exclusion Criteria:i. Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment. ii. Patients who have more than one tooth in the same quadrant and/or opposite quadrant that require an endodontic treatment. iii. Pregnant females. iv. Patients having significant systemic disorder. v. If antibiotics have been administrated during the past two weeks preoperatively. vi. Patients having bruxism or clenching. vii. 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
    Asmaa M kamel, Student
    Phone
    01010266628
    Email
    asmaa.kamal@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shaimaa I Gawdat, Lecturer
    Phone
    01222235502
    Email
    shaimaagawdat@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shaimaa I Gawdat, Lecturer
    Organizational Affiliation
    Department of endodontics - Faculty of Oral and Dental medicine - CU
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Angie G Ghoneim, Professor
    Organizational Affiliation
    Department of endodontics - Faculty of Oral and Dental medicine - CU
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Asmaa M kamel, Student
    Organizational Affiliation
    Department of endodontics - Faculty of Oral and Dental medicine - CU
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Assessment of Postoperative Pain Using Reciproc Versus One Shape Files in Patients With Irreversible Pulpitis

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