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Postoperative Pain Endodontic Retreatment

Primary Purpose

Endodontically Treated Teeth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-surgical endodontic retreatment in single visit
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontically Treated Teeth

Eligibility Criteria

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

Inclusion Criteria:

  • Clinically asymptomatic.
  • Previously treated teeth in need of retreatment due to leakage and/or improper filling.
  • No periapical radiolucency.
  • No percussion pains.
  • Age 20 - 45.
  • Premolar teeth.
  • Male & female.

Exclusion Criteria:

  • Complicating compromised patient.
  • Tenderness to percussion and acute apical abscess.
  • Presence of an associated sinus tract.
  • Presence of swelling in adjacent soft tissue.
  • Teeth with periodontal pathologies or mobility.
  • Teeth representing root fracture.
  • Pregnant women.
  • If analgesics or antibiotics have been administrated by the patient during the past 24 hours.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    group 1 Non-surgical endodontic retreatment in single visit

    group 2 Non-surgical endodontic retreatment in Two-visit

    Arm Description

    Single visit treatments have gained more popularity. Completing the treatment in a single appointment has many advantages including reduction in treatment time and cost, lower risk of micro leakage and recontamination of root canals between appointments

    Two-visit endodontic treatment with intra-canal medication was traditionally found to be effective in decreasing the number of flare-up in all retreatment cases and in reducing postoperative pain of previously symptomatic teeth

    Outcomes

    Primary Outcome Measures

    Incidence and intensity of postoperative
    Evaluate incidence and intensity of postoperative pain at 6,12,24, 48hours , and one week using numerical visual scale (NRS) after each visit endodontic retreatment

    Secondary Outcome Measures

    Number of analgesic tablets
    Number of analgesic tablets taken by the patient after endodontic retreatment

    Full Information

    First Posted
    May 5, 2020
    Last Updated
    October 7, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04580862
    Brief Title
    Postoperative Pain Endodontic Retreatment
    Official Title
    Incidence Postoperative Pain After Single Visit Versus Two Visit Nonsurgical Endodontic Retreatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    May 2021 (Anticipated)
    Study Completion Date
    June 2021 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    To compare the incidence of post-operative pain after single-visit versus two-visit non-surgical endodontic retreatment.
    Detailed Description
    Post treatment failure could be treated by two options including orthograde retreatment and apical surgery . In a previous study, orthograde retreatments presented a success rate of 81 % classified as healed and 93 % as no symptoms and fully functional. In a systematic review, it has also been concluded that endodontic surgery offers more favorable initial success but orthograde retreatment yields to a better long-term outcome . Although early results of single-visit treatments are contradictory ; Completing the treatment in a single appointment reduces the treatment time and cost, decreases micro leakage risk and avoids recontamination of root canals between appointments in multiple-visit treatments . Again, reviewing the literature concerning primary treatment showed that, no significant differences were observed in healing of periapical radiolucency between teeth treated in single-visit and those treated in two-visits. Even, after using calcium hydroxide for four weeks . The presence of a positive bacterial culture at the time of filling did not influence the outcome of treatment . Thorough online search revealed that, few studies are found concerning post- operative pain after single visit retreatment . The present study is designed to compare the effects of single-visit and two-visit root canal treatments on postoperative pain in retreatment cases. The primary outcome measure of this study is proposed to be whether single-visit root canal retreatment influenced the occurrence of postoperative pain as compared to two-visit treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endodontically Treated Teeth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    62 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group 1 Non-surgical endodontic retreatment in single visit
    Arm Type
    Experimental
    Arm Description
    Single visit treatments have gained more popularity. Completing the treatment in a single appointment has many advantages including reduction in treatment time and cost, lower risk of micro leakage and recontamination of root canals between appointments
    Arm Title
    group 2 Non-surgical endodontic retreatment in Two-visit
    Arm Type
    Active Comparator
    Arm Description
    Two-visit endodontic treatment with intra-canal medication was traditionally found to be effective in decreasing the number of flare-up in all retreatment cases and in reducing postoperative pain of previously symptomatic teeth
    Intervention Type
    Other
    Intervention Name(s)
    Non-surgical endodontic retreatment in single visit
    Other Intervention Name(s)
    Non-surgical endodontic retreatment in Two-visit
    Intervention Description
    Full medical and dental history using a schematic dental chart, will be obtained from all patients treated during this study.
    Primary Outcome Measure Information:
    Title
    Incidence and intensity of postoperative
    Description
    Evaluate incidence and intensity of postoperative pain at 6,12,24, 48hours , and one week using numerical visual scale (NRS) after each visit endodontic retreatment
    Time Frame
    At one week after each visit
    Secondary Outcome Measure Information:
    Title
    Number of analgesic tablets
    Description
    Number of analgesic tablets taken by the patient after endodontic retreatment
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Clinically asymptomatic. Previously treated teeth in need of retreatment due to leakage and/or improper filling. No periapical radiolucency. No percussion pains. Age 20 - 45. Premolar teeth. Male & female. Exclusion Criteria: Complicating compromised patient. Tenderness to percussion and acute apical abscess. Presence of an associated sinus tract. Presence of swelling in adjacent soft tissue. Teeth with periodontal pathologies or mobility. Teeth representing root fracture. Pregnant women. If analgesics or antibiotics have been administrated by the patient during the past 24 hours.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30054099
    Citation
    Erdem Hepsenoglu Y, Eyuboglu TF, Ozcan M. Postoperative Pain Intensity after Single- versus Two-visit Nonsurgical Endodontic Retreatment: A Randomized Clinical Trial. J Endod. 2018 Sep;44(9):1339-1346. doi: 10.1016/j.joen.2018.05.017. Epub 2018 Jul 24.
    Results Reference
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    Postoperative Pain Endodontic Retreatment

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