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"Effect of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain"

Primary Purpose

Postoperative Pain, Endodontically Treated Teeth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Apical enlargement
Apical enlargement + Sonic Activation Assisted Irrigation
Non Apical enlargement
Non Apical enlargement + Sonic Activation Assisted Irrigation
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Endodontics, Postoperative Pain, Visual Analogue Pain Scale

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

-Patients who were healthy volunteers and who have failed teeth required retreatment with periapical index score 3-5 score requiring root canal treatment for first time.

Patients who were not included the study who;

  • were pregnant or breast feeding during the duration of the study,
  • have systemic disease, have any pain and/or any facial swelling, abscess,
  • were immunocompromised,
  • were under 18 yrs. and over 65 yrs. age,
  • were taking antibiotics or corticosteroids within previous three days,
  • have multiple teeth that required root canal treatment at the same time period; for eliminating pain referral,
  • have root canals that could not be well-treated with orthograde retreatment.

Exclusion Criteria:

-The patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Apical enlargement

    Apical enlargement + Sonic Activation Assisted Irrigation

    Non Apical enlargement

    Non Apical enlargement + Sonic Activation Assisted Irrigation

    Arm Description

    Routine retreatment procedure will be performed at working length according to the apex locator at point "0".

    Routine retreatment procedure will be performed at working length according to the apex locator at point "0" and sonic activation assisted irrigation will be applied.

    Routine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point.

    Routine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point and sonic activation assisted irrigation will be applied.

    Outcomes

    Primary Outcome Measures

    Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week: VAS
    The primary outcome measure of the study is to assess if sonic activation assisted irrigation and apical enlargement procedures influence the occurrence of postoperative pain.Postoperative pain was assessed using a well defined Heft-Parker visual analogue scale (VAS) scale. Each patient recorded the pain level on a 100-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 12, 24, 48, 72 hours and 1 week after treatment. The VAS scale was divided into 4 categories: No pain or faint pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 25 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 50 mm and less than 75 mm. Intense pain was defined as equal to or greater than 75 mm. Intense pain included the descriptors of strong, severe, and maximum possible.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 17, 2020
    Last Updated
    April 29, 2020
    Sponsor
    Istanbul Medipol University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04314908
    Brief Title
    "Effect of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain"
    Official Title
    The Clinical Comparative Evaluation of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain In Retreatment: A Prospective Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 10, 2020 (Anticipated)
    Primary Completion Date
    October 10, 2020 (Anticipated)
    Study Completion Date
    December 10, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    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
    The purpose of this randomized clinical trial is to evaluate the incidence of postoperative pain after retreatment after apical enlargement and sonic activation assisted irrigation. The presence of postoperative pain will assess after retreatment cases at 12, 24, 48, 72 hrs and 1 week.
    Detailed Description
    The aim of this clinical study is to evaluate the intensity and duration of postoperative pain after apical enlargement and sonic activation assisted irrigation procedures. Patients who have asymptomatic teeth required retreatment will include in this study and retreatment procedure will be applied to these teeth. One hundreds twenty asymptomatic teeth required retreatment will randomly participate into 4 treatment groups in terms of apical enlargement and sonic activation assisted irrigation procedure applied. The presence of postoperative pain will assess after 12, 24, 48, 72 hrs and 1 week. Postoperative pain will be recorded by each patient by using visual analogue pain scale. Before the treatments, the nature of the study, complications and associated risks will be totally explained and written informed consent will be obtained from all study participants. The local anesthetic will be applied before the treatment start. The routine retreatment procedure will be applied. Different final irrigation solutions will be applied in accordance to the manufacturers' instructions. At the end of treatment, each patient will be given an evaluation sheet, explained the treatment procedure and using of visual analogue pain scales, and informed to be returned during the following one week. After one week the teeth will be 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
    Postoperative Pain, Endodontically Treated Teeth
    Keywords
    Endodontics, Postoperative Pain, Visual Analogue Pain Scale

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel Assignment The patients were assigned to 4 medication groups randomly with an equal allocation rate between groups.The patients in the groups had same characteristics.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Double (Participant and Outcomes Assessor) The patients and outcome assessor were unaware as to which study group they had been allocated.
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Apical enlargement
    Arm Type
    Experimental
    Arm Description
    Routine retreatment procedure will be performed at working length according to the apex locator at point "0".
    Arm Title
    Apical enlargement + Sonic Activation Assisted Irrigation
    Arm Type
    Experimental
    Arm Description
    Routine retreatment procedure will be performed at working length according to the apex locator at point "0" and sonic activation assisted irrigation will be applied.
    Arm Title
    Non Apical enlargement
    Arm Type
    Experimental
    Arm Description
    Routine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point.
    Arm Title
    Non Apical enlargement + Sonic Activation Assisted Irrigation
    Arm Type
    Experimental
    Arm Description
    Routine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point and sonic activation assisted irrigation will be applied.
    Intervention Type
    Procedure
    Intervention Name(s)
    Apical enlargement
    Intervention Description
    The teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will be opened. The working length will be measured using apex locator and the "0" point will be based on. After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary.
    Intervention Type
    Procedure
    Intervention Name(s)
    Apical enlargement + Sonic Activation Assisted Irrigation
    Intervention Description
    The teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will open. The working length will be measured using apex locator and the "0" point will be based on. After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals. Then the teeth were obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary.
    Intervention Type
    Procedure
    Intervention Name(s)
    Non Apical enlargement
    Intervention Description
    The teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will open. The working length will be measured using apex locator and 1 mm shorter than the "0" point will be based on. After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary.
    Intervention Type
    Procedure
    Intervention Name(s)
    Non Apical enlargement + Sonic Activation Assisted Irrigation
    Intervention Description
    The teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will open. The working length will be measured using apex locator and 1 mm shorter than the "0" point will be based on. After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals. Then the teeth were obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary.
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week: VAS
    Description
    The primary outcome measure of the study is to assess if sonic activation assisted irrigation and apical enlargement procedures influence the occurrence of postoperative pain.Postoperative pain was assessed using a well defined Heft-Parker visual analogue scale (VAS) scale. Each patient recorded the pain level on a 100-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 12, 24, 48, 72 hours and 1 week after treatment. The VAS scale was divided into 4 categories: No pain or faint pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 25 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 50 mm and less than 75 mm. Intense pain was defined as equal to or greater than 75 mm. Intense pain included the descriptors of strong, severe, and maximum possible.
    Time Frame
    Baseline, 12, 24, 48, 72 hours and 1 week.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: -Patients who were healthy volunteers and who have failed teeth required retreatment with periapical index score 3-5 score requiring root canal treatment for first time. Patients who were not included the study who; were pregnant or breast feeding during the duration of the study, have systemic disease, have any pain and/or any facial swelling, abscess, were immunocompromised, were under 18 yrs. and over 65 yrs. age, were taking antibiotics or corticosteroids within previous three days, have multiple teeth that required root canal treatment at the same time period; for eliminating pain referral, have root canals that could not be well-treated with orthograde retreatment. Exclusion Criteria: -The patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Keziban Olcay, DDS, PhD
    Phone
    05423385708
    Email
    kolcay@medipol.edu.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Keziban Olcay, DDS, Phd
    Organizational Affiliation
    Medipol University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    "Effect of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain"

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