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Postoperative Pain Intensity Associated With the Use of Different Nickel Titanium Instrumentation Systems

Primary Purpose

Pain, Postoperative, Endodontically Treated Teeth

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group 1: single file rotary motion
Group 2: multiple file rotary motion
Group 3: single file reciprocal motion
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Pain, Postoperative focused on measuring Endodontic retreatment, postoperative pain, OneShape, Revo-S, WaveOne

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Asymptomatic teeth
  • Patients with no contradictory medical history
  • Patients who were indicated for non-surgical retreatment and
  • Patients who were above 18 years old

Exclusion Criteria:

  • Patients aged below 18 years;
  • Symptomatic teeth,
  • Teeth with vertical root fractures
  • Teeth with excessive periodontal disease;
  • Patients who received or required surgical endodontic treatment
  • Patients diagnosed with systemic diseases
  • Patients who used analgesics 12 h before or
  • Patients who used antibiotics 1 month before the retreatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group 1: single file rotary motion

    Group 2: multiple file rotary motion

    Group 3: single file reciprocal motion

    Arm Description

    after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using OneShape Ni-Ti system.

    after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using Revo S Ni-Ti system.

    after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using WaveOne Ni-Ti system.

    Outcomes

    Primary Outcome Measures

    Change from Baseline in Postoperative Pain after single appointment retreatment at 1 month
    The primary outcome measure of the study was to assess if different nickel titanium root canal shaping systems influence the intensity and duration of postoperative pain in single-visit non-surgical root canal re-treatments. Postoperative pain was recorded using a four-level verbal rating scale, where 0 indicated no pain, 1 indicated slight pain, 2 indicated moderate pain, and 3 indicated sever pain. the patients were asked to return to the clinic for assessing postoperative pain (tenderness to palpation and percussion) at 24, 48, and 72 h; 7 days; and 1 month after the treatment. One clinician performed all the assessments at 24, 48, and 72 h; 7 days; and 1 month.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 14, 2018
    Last Updated
    March 26, 2018
    Sponsor
    Istanbul Medipol University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03478241
    Brief Title
    Postoperative Pain Intensity Associated With the Use of Different Nickel Titanium Instrumentation Systems
    Official Title
    Postoperative Pain Intensity Associated With the Use of Different Nickel Titanium Instrumentation Systems During Single-Appointment Non-Surgical Endodontic Retreatment: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2016 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    January 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul Medipol University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this study the effect of different engine-driven nickel titanium (Ni-Ti) instrumentation systems (OneShape, Revo S and WaveOne) on postoperative dental pain in patients with asymptomatic teeth after a single-appointment root canal retreatment was evaluated.
    Detailed Description
    The aim of this clinical study was to evaluate the effect of different engine-driven nickel titanium (Ni-Ti) instrumentation systems (OneShape, Revo S and WaveOne) on postoperative dental pain in patients with asymptomatic teeth after a single-appointment root canal retreatment. A total of a hundred thirty nine patients with asymptomatic teeth and with no contradictory medical history who were indicated for non-surgical retreatment at the Endodontic Clinic, Faculty of Dentistry, Istanbul Medipol University, between September and December 2016 were included in this study. All of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. Out of a hundred thirty nine patients, a total of ninety-nine patients who met the inclusion criteria and agreed to participate was enrolled for the study and were divided into three groups (n=33). Consent was obtained from all study participants before the treatment. After removing previous root canal filling, instrumentation was performed using One Shape, Revo-S, and WaveOne in groups 1, 2, and 3, respectively. All retreatments were performed in a single appointment by one endodontist before permanent coronal restoration. Postoperative pain intensity was assessed at 6, 12, 18, 24, 48, and 72 h; 7 days; and 1 month after the retreatment. The teeth was examined according to for pain intensity, percussion & palpation sensitivity, swelling, analgesic intake and clinical status.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative, Endodontically Treated Teeth
    Keywords
    Endodontic retreatment, postoperative pain, OneShape, Revo-S, WaveOne

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    after each group has been treated with their respective Ni-Ti root canal shaping system, post operative pain was assessed at 6, 12, 18, 24, 48, and 72 h; 7 days; and 1 month.
    Masking
    Participant
    Masking Description
    the patient did not know which shaping system was used on them
    Allocation
    Randomized
    Enrollment
    99 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1: single file rotary motion
    Arm Type
    Active Comparator
    Arm Description
    after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using OneShape Ni-Ti system.
    Arm Title
    Group 2: multiple file rotary motion
    Arm Type
    Active Comparator
    Arm Description
    after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using Revo S Ni-Ti system.
    Arm Title
    Group 3: single file reciprocal motion
    Arm Type
    Active Comparator
    Arm Description
    after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using WaveOne Ni-Ti system.
    Intervention Type
    Device
    Intervention Name(s)
    Group 1: single file rotary motion
    Other Intervention Name(s)
    OneShape
    Intervention Description
    after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using OneShape Ni-Ti system. the obturation process was completed prior to coronal restoration either with direct or indirect methods
    Intervention Type
    Device
    Intervention Name(s)
    Group 2: multiple file rotary motion
    Other Intervention Name(s)
    Revo S
    Intervention Description
    after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using Revo S Ni-Ti system. the obturation process was completed prior to coronal restoration either with direct or indirect methods
    Intervention Type
    Device
    Intervention Name(s)
    Group 3: single file reciprocal motion
    Other Intervention Name(s)
    WaveOne
    Intervention Description
    after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using WaveOne Ni-Ti system. the obturation process was completed prior to coronal restoration either with direct or indirect methods
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Postoperative Pain after single appointment retreatment at 1 month
    Description
    The primary outcome measure of the study was to assess if different nickel titanium root canal shaping systems influence the intensity and duration of postoperative pain in single-visit non-surgical root canal re-treatments. Postoperative pain was recorded using a four-level verbal rating scale, where 0 indicated no pain, 1 indicated slight pain, 2 indicated moderate pain, and 3 indicated sever pain. the patients were asked to return to the clinic for assessing postoperative pain (tenderness to palpation and percussion) at 24, 48, and 72 h; 7 days; and 1 month after the treatment. One clinician performed all the assessments at 24, 48, and 72 h; 7 days; and 1 month.
    Time Frame
    6, 12, 18, 24, 48, and 72 h; 7 days; and 1 month
    Other Pre-specified Outcome Measures:
    Title
    unscheduled appointment for emergency intervention
    Description
    the presence or absence of unscheduled appointment for emergency dental intervention was recorded on the chart of the patient as "present" or "absent" during the observation time
    Time Frame
    1 month
    Title
    presence of complications
    Description
    the absence or presence of complications (such as swelling or parasthesia) after the intervention was recorded on the chart of the patient as "present" or "absent" during the observation time
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Asymptomatic teeth Patients with no contradictory medical history Patients who were indicated for non-surgical retreatment and Patients who were above 18 years old Exclusion Criteria: Patients aged below 18 years; Symptomatic teeth, Teeth with vertical root fractures Teeth with excessive periodontal disease; Patients who received or required surgical endodontic treatment Patients diagnosed with systemic diseases Patients who used analgesics 12 h before or Patients who used antibiotics 1 month before the retreatment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    TAN FIRAT EYUBOGLU, DDS, PhD
    Organizational Affiliation
    Medipol University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Postoperative Pain Intensity Associated With the Use of Different Nickel Titanium Instrumentation Systems

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