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Effect of Cryotherapy Versus Post-operative Ibuprofen Medication on Post-operative Pain in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis

Primary Purpose

Symptomatic Irreversible Pulpitis

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
cold saline (cryotherapy)
Ibuprofen 400 mg
Final irrigation with normal saline
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Irreversible Pulpitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: - Patients above 18 years old and to 60.

  • Male or female.
  • Patients seeking root canal treatment.
  • Molar teeth with Symptomatic irreversible pulpitis with preoperative sharp, moderate, or severe pain with normal periapical radiographic appearance or slight widening in lamina dura.
  • Systematically healthy patient (ASA I).
  • Patient who can understand VAS and sign informed consent.

Exclusion Criteria:

  • Medically compromised patients having significant systemic disorders including cardiovascular, respiratory, and gastrointestinal diseases (ASA II, III or IV).
  • History of intolerance to NSAIDS.
  • Patients with two or more adjacent teeth requiring endodontic treatment.
  • External root resorption.
  • Internal root resorption.
  • Vertical root fracture.
  • Periapical lesion.
  • Pregnancy.
  • Use of ibuprofen in the last 12 hour.
  • Bleeding disorder.
  • Long term corticosteroid use. 10
  • Mobility Grade II or III.
  • Pocket depth more than 5mm.
  • Previous root canal therapy.
  • Non-restorability.
  • TMJ problems, bruxism, clenching or traumatic occlusion.
  • Inability to perceive the given instructions.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Final irrigation with cold saline (cryotherapy).

    Ibuprofen post-operative medication.

    Final irrigation with normal saline, and no post-operative medication

    Arm Description

    20ml of 2.5°C cold saline for 5 min

    a single dose of Ibuprofen 400 mg immediately after completion of root canal treatment

    final irrigation will be done using normal saline at room temperature.

    Outcomes

    Primary Outcome Measures

    Post-operative pain
    The pain will be recorded using the modified visual analogue scale (VAS). • 0, "no pain" 1-3, "mild pain" 4-6, "moderate pain" 7-10, "severe pain" "10" being the most intense pain conceivable.
    Post-operative pain
    The pain will be recorded using the modified visual analogue scale (VAS). • 0, "no pain" 1-3, "mild pain" 4-6, "moderate pain" 7-10, "severe pain" "10" being the most intense pain conceivable.
    Post-operative pain
    The pain will be recorded using the modified visual analogue scale (VAS). • 0, "no pain" 1-3, "mild pain" 4-6, "moderate pain" 7-10, "severe pain" "10" being the most intense pain conceivable.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 14, 2022
    Last Updated
    April 21, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05341999
    Brief Title
    Effect of Cryotherapy Versus Post-operative Ibuprofen Medication on Post-operative Pain in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis
    Official Title
    Evaluation of the Effect of Cryotherapy Versus Post-operative Ibuprofen Medication on Post-operative Pain in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2022 (Anticipated)
    Primary Completion Date
    April 2023 (Anticipated)
    Study Completion Date
    May 2023 (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
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Evaluation of the effect of cryotherapy versus post-operative ibuprofen medication on post-operative pain in mandibular molar teeth with symptomatic irreversible pulpitis . a new technique was proposed to utilize the effect of cold saline on reducing the inflammatory process in the tissue, the so-called cryotherapy.
    Detailed Description
    PICO/ Population: Molar teeth with symptomatic irreversible pulpitis. Intervention I: Final irrigation with cold saline (cryotherapy). Intervention II: Ibuprofen post-operative medication. Control: Final irrigation with normal saline, and no post-operative medication. Outcome: Post- operative pain. Sequence of Procedural steps: Full medical and dental history will be obtained from all the patients . Thorough clinical and radiographic examination for the tooth to be treated will be done. The tooth will be anaesthetized and Access cavity will be performed. The canals will be thoroughly irrigated using 3ml syringe of Sodium hypochlorite after every instrument. Canals will be dried using sterile paper points. In the intervention group 1, cryotherapy irrigation will be done using 20ml of 2.5°C cold saline for 5 min, the cold saline will be stored in an icebox with a thermometer calibrated at 2.5°C. In the intervention group 2, the patients will be prescribed ibuprofen medication as a single dose immediately after completion of root canal treatment. In the control group, final irrigation will be done using normal saline at room temperature. Canals will be dried using sterile paper points, and then filled with gutta percha cones corresponding to the same size of the final shaping file and sealed with sealer. The access cavity will then be closed with temporary filling. Post-operative instructions will be given to all patients. • The patient will be asked to rate their pain level according to the given instructions and telecommunication will be scheduled after 3 days to collect the VAS scores and assess the outcome of the treatment. The patients who will be suffered from severe pain, analgesic will be prescribed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Symptomatic Irreversible Pulpitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Final irrigation with cold saline (cryotherapy).
    Arm Type
    Experimental
    Arm Description
    20ml of 2.5°C cold saline for 5 min
    Arm Title
    Ibuprofen post-operative medication.
    Arm Type
    Experimental
    Arm Description
    a single dose of Ibuprofen 400 mg immediately after completion of root canal treatment
    Arm Title
    Final irrigation with normal saline, and no post-operative medication
    Arm Type
    Active Comparator
    Arm Description
    final irrigation will be done using normal saline at room temperature.
    Intervention Type
    Other
    Intervention Name(s)
    cold saline (cryotherapy)
    Intervention Description
    using 20ml of 2.5°C cold saline for 5 min
    Intervention Type
    Drug
    Intervention Name(s)
    Ibuprofen 400 mg
    Intervention Description
    patients will be prescribed ibuprofen medication as a single dose immediately after completion of root canal treatment.
    Intervention Type
    Other
    Intervention Name(s)
    Final irrigation with normal saline
    Intervention Description
    final irrigation will be done using normal saline at room temperature.
    Primary Outcome Measure Information:
    Title
    Post-operative pain
    Description
    The pain will be recorded using the modified visual analogue scale (VAS). • 0, "no pain" 1-3, "mild pain" 4-6, "moderate pain" 7-10, "severe pain" "10" being the most intense pain conceivable.
    Time Frame
    6 hours post-operatively
    Title
    Post-operative pain
    Description
    The pain will be recorded using the modified visual analogue scale (VAS). • 0, "no pain" 1-3, "mild pain" 4-6, "moderate pain" 7-10, "severe pain" "10" being the most intense pain conceivable.
    Time Frame
    24 hours post-operatively
    Title
    Post-operative pain
    Description
    The pain will be recorded using the modified visual analogue scale (VAS). • 0, "no pain" 1-3, "mild pain" 4-6, "moderate pain" 7-10, "severe pain" "10" being the most intense pain conceivable.
    Time Frame
    48 hours post-operatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - Patients above 18 years old and to 60. Male or female. Patients seeking root canal treatment. Molar teeth with Symptomatic irreversible pulpitis with preoperative sharp, moderate, or severe pain with normal periapical radiographic appearance or slight widening in lamina dura. Systematically healthy patient (ASA I). Patient who can understand VAS and sign informed consent. Exclusion Criteria: Medically compromised patients having significant systemic disorders including cardiovascular, respiratory, and gastrointestinal diseases (ASA II, III or IV). History of intolerance to NSAIDS. Patients with two or more adjacent teeth requiring endodontic treatment. External root resorption. Internal root resorption. Vertical root fracture. Periapical lesion. Pregnancy. Use of ibuprofen in the last 12 hour. Bleeding disorder. Long term corticosteroid use. 10 Mobility Grade II or III. Pocket depth more than 5mm. Previous root canal therapy. Non-restorability. TMJ problems, bruxism, clenching or traumatic occlusion. Inability to perceive the given instructions.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yousef H Abuhelal, Master
    Phone
    +201033054851
    Email
    yousefhassan@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Radwa S Emara, PHD
    Phone
    +201272141312
    Email
    radwa.emara@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Cryotherapy Versus Post-operative Ibuprofen Medication on Post-operative Pain in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis

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