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Comparative Evaluation of the Efficacy of Intraoral Cryotherapy Versus Intracanal Cryotherapy on Postoperative Pain

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intraoral Cryotherapy
Intracanal Cryotherapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

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

Inclusion Criteria:

Systemically healthy patient (ASA I or II).

Mandibular first molar teeth with:

  • Preoperative sharp pain and symptomatic apical periodontitis
  • Absence or slight widening in the periodontal ligament (PDL).
  • Vital response of pulp tissue to cold pulp tester (ethyl chloride spray) .
  • Positive response to percussion test

Exclusion Criteria:

  1. Medically compromised patients.
  2. Pregnant women.
  3. Patients reporting bruxism or clenching.
  4. Patients allergic to ciprofloxacin or metronidazole.
  5. Teeth associated with acute periapical abscess and/or swelling.
  6. Greater than grade I mobility or pocket depth greater than 5mm.
  7. Size of periapical radiolucency is greater than 8 mm.
  8. No restorability: Hopeless tooth.
  9. Immature teeth.
  10. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intraoral Cryotherapy

    Intracanal Cryotherapy

    Arm Description

    Outcomes

    Primary Outcome Measures

    Postoperative pain assessed using Visual Analogue scale
    Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
    Postoperative pain assessed using Visual Analogue scale
    Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
    Postoperative pain assessed using Visual Analogue scale
    Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."

    Secondary Outcome Measures

    Postoperative pain assessed using Visual Analogue scale
    Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
    Postoperative pain assessed using Visual Analogue scale
    Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."

    Full Information

    First Posted
    September 8, 2021
    Last Updated
    September 8, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05041738
    Brief Title
    Comparative Evaluation of the Efficacy of Intraoral Cryotherapy Versus Intracanal Cryotherapy on Postoperative Pain
    Official Title
    Comparative Evaluation of the Efficacy of Intraoral Cryotherapy Versus Intracanal Cryotherapy on Postoperative Pain in Lower Molar Teeth With Irreversible Pulpitis and Symptomatic Apical Periodontitis Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2021 (Anticipated)
    Primary Completion Date
    October 1, 2022 (Anticipated)
    Study Completion Date
    October 1, 2022 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to clinically compare the efficacy of intraoral cryotherapy versus intracanal cryotherapy after single visit root canal therapy in lower molars with irreversible pulpitis and symptomatic apical periodontitis

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Intraoral Cryotherapy
    Arm Type
    Experimental
    Arm Title
    Intracanal Cryotherapy
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Intraoral Cryotherapy
    Intervention Description
    small ice packs wrapped in sterile gauze placed in the mouth on the vestibular surface of the treated tooth
    Intervention Type
    Procedure
    Intervention Name(s)
    Intracanal Cryotherapy
    Intervention Description
    Intracanal cryotherapy technique using 2.5°C cold saline irrigation as final irrigant
    Primary Outcome Measure Information:
    Title
    Postoperative pain assessed using Visual Analogue scale
    Description
    Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
    Time Frame
    6 hours post treatment
    Title
    Postoperative pain assessed using Visual Analogue scale
    Description
    Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
    Time Frame
    12 hours post treatment
    Title
    Postoperative pain assessed using Visual Analogue scale
    Description
    Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
    Time Frame
    24 hours post treatment
    Secondary Outcome Measure Information:
    Title
    Postoperative pain assessed using Visual Analogue scale
    Description
    Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
    Time Frame
    48 hours post treatment
    Title
    Postoperative pain assessed using Visual Analogue scale
    Description
    Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
    Time Frame
    72 hours post treatment
    Other Pre-specified Outcome Measures:
    Title
    Number of analgesics taken by the patient
    Description
    Number of analgesics taken by the patient after endodontic treatment.
    Time Frame
    Up to 72 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Systemically healthy patient (ASA I or II). Mandibular first molar teeth with: Preoperative sharp pain and symptomatic apical periodontitis Absence or slight widening in the periodontal ligament (PDL). Vital response of pulp tissue to cold pulp tester (ethyl chloride spray) . Positive response to percussion test Exclusion Criteria: Medically compromised patients. Pregnant women. Patients reporting bruxism or clenching. Patients allergic to ciprofloxacin or metronidazole. Teeth associated with acute periapical abscess and/or swelling. Greater than grade I mobility or pocket depth greater than 5mm. Size of periapical radiolucency is greater than 8 mm. No restorability: Hopeless tooth. Immature teeth. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Toka M Ezzat, B.D.S. (Cairo University)
    Phone
    01005137002
    Ext
    002
    Email
    toka.ezzat@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    32386857
    Citation
    Fayyad DM, Abdelsalam N, Hashem N. Cryotherapy: A New Paradigm of Treatment in Endodontics. J Endod. 2020 Jul;46(7):936-942. doi: 10.1016/j.joen.2020.03.019. Epub 2020 May 6.
    Results Reference
    background
    PubMed Identifier
    29398090
    Citation
    Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3.
    Results Reference
    background

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    Comparative Evaluation of the Efficacy of Intraoral Cryotherapy Versus Intracanal Cryotherapy on Postoperative Pain

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